TruVascular Access - Ultrasound-Guided Vascular Access Study (TVA-2026)

August 27, 2026 updated by: Truway Health, Inc.

A Prospective Randomized Controlled Study Comparing Ultrasound-Guided Peripheral Vascular Access With Standard Landmark/Palpation-Guided Access for Improving First-Attempt Cannulation Success

TruVascular Access - TVA-2026 is a prospective, randomized clinical study evaluating whether ultrasound-guided peripheral vascular access improves first-attempt cannulation success compared with conventional landmark, visualization, and palpation-guided techniques in adults who require clinically indicated peripheral venous access.

Participants will be assigned to either an ultrasound-guided vascular-access workflow or a standard vascular-access workflow. The primary outcome is successful placement of a functional peripheral vascular catheter on the first cannulation attempt. Secondary outcomes include the total number of cannulation attempts, time to successful vascular access, successful access within two attempts, need for rescue or escalation to another vascular-access method, patient-reported procedural pain, access-related complications, catheter function, and operator-reported procedural difficulty.

The study will also collect information about participant characteristics, difficult intravenous access features, vascular anatomy, catheter characteristics, operator experience, and other procedural factors that may influence successful vascular access. These data may be used to identify patient and procedural characteristics associated with first-attempt success and to improve future vascular-access workflows.

Participant safety will take priority over study assignment. If the assigned technique is unsuccessful or clinically inappropriate, the treating clinician may use an alternative or rescue vascular-access method according to applicable clinical practice and study procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Peripheral vascular access is routinely required for the administration of intravenous medications, fluids, diagnostic contrast, blood products, infusion therapies, blood sampling, perioperative care, and other clinical procedures. Although peripheral intravenous catheter placement is common, successful cannulation may be difficult in some patients because of vessel depth, small vessel diameter, limited vein visibility or palpability, body habitus, prior vascular-access procedures, chronic illness, or other anatomical and clinical factors.

Repeated unsuccessful cannulation attempts may increase patient discomfort, procedure duration, clinician workload, use of medical supplies, and the likelihood that the patient will require assistance from another clinician or escalation to a more advanced vascular-access procedure. Real-time ultrasound allows clinicians to visualize peripheral vessels and surrounding anatomy during vascular-access procedures and may therefore improve vessel selection and needle guidance, particularly in patients with difficult intravenous access.

TVA-2026 is designed to prospectively compare an ultrasound-guided peripheral vascular-access workflow with conventional vascular-access techniques based primarily on visualization, palpation, and anatomical landmarks.

Participants who require clinically indicated peripheral vascular access and meet study eligibility requirements will be randomized in a 1:1 ratio to one of two study groups.

Ultrasound-Guided Vascular Access Group

Participants assigned to the ultrasound-guided group will undergo peripheral vascular-access placement using real-time ultrasound visualization. The clinician will identify an appropriate peripheral vessel and perform cannulation using a standardized ultrasound-guided approach consistent with the approved study protocol, institutional practice, device instructions for use, and operator training requirements.

Where applicable, the study may document vessel characteristics including vessel depth, estimated vessel diameter, anatomical location, compressibility, selected catheter characteristics, and procedural approach.

Standard Vascular Access Group

Participants assigned to the standard-access group will initially undergo peripheral vascular-access placement using conventional methods such as visual inspection, palpation, anatomical landmarks, tourniquet-assisted vein identification, and other standard clinical techniques that do not initially require real-time ultrasound guidance.

If standard access is unsuccessful within the protocol-defined number of attempts, the treating clinician may use an appropriate rescue technique. Rescue may include ultrasound guidance, assistance from another clinician, use of an alternative anatomical site, or escalation to another clinically appropriate vascular-access method.

Primary Outcome

The primary outcome is first-attempt cannulation success.

First-attempt success will be defined according to the final protocol as successful placement of a functional peripheral vascular catheter following the first needle insertion attempt associated with the assigned vascular-access procedure.

Functional access may be confirmed using clinically appropriate methods such as blood return, successful saline flush, absence of immediate infiltration, or another protocol-defined confirmation procedure.

Secondary Outcomes

Secondary outcomes may include:

Number of cannulation attempts required for successful vascular access. Successful vascular access within two attempts. Time from initiation of the vascular-access procedure to successful catheter placement.

Need for assistance from another clinician. Need for crossover from the initially assigned access method. Need for ultrasound rescue. Need for midline, peripherally inserted central catheter, central venous catheter, or another alternative form of vascular access.

Patient-reported procedural pain. Patient-reported satisfaction with the vascular-access procedure. Operator-reported procedural difficulty. Operator confidence and satisfaction. Number of catheters or related procedural supplies used before successful access.

Immediate vascular-access complications. Catheter function and premature catheter failure during follow-up when such follow-up is clinically feasible.

Safety Outcomes

Potential access-related safety events may include:

Hematoma. Bleeding. Infiltration. Extravasation. Accidental arterial puncture. Phlebitis. Local infection. Catheter dislodgement. Premature catheter failure. Thrombosis or other clinically significant vascular complications. Other adverse events judged to be related to the vascular-access procedure or study device.

The occurrence, severity, clinical significance, relatedness, and outcome of applicable adverse events will be documented according to the study safety-monitoring plan.

Difficult Intravenous Access Assessment

TVA-2026 will include characterization of participants with potentially difficult intravenous access. Relevant variables may include:

Previous history of difficult vascular access. Poorly visible peripheral veins. Poorly palpable peripheral veins. Previous multiple-attempt catheter placement. Body mass index. Prior vascular procedures. Chronic illness or treatment associated with reduced peripheral venous accessibility.

Other predefined difficult-access characteristics.

A prespecified subgroup analysis may compare study outcomes between participants classified as having difficult intravenous access and those without such classification.

Procedural and Ultrasound Variables

Where available and appropriate to the final protocol, the study may collect additional variables including:

Vessel diameter. Vessel depth. Anatomical access site. Vessel compressibility. Catheter gauge. Catheter length. Needle approach. Ultrasound imaging orientation. Operator training level. Operator vascular-access experience. Operator ultrasound experience. Number of potential vessels identified. Relationship between catheter characteristics and vascular anatomy.

These variables may be evaluated to determine whether specific patient, anatomical, device, or operator characteristics are associated with successful vascular access.

Participant Safety and Rescue Access

Participant safety and medically necessary care will take priority over research procedures.

Participation in TVA-2026 will not require clinicians to continue repeated unsuccessful attempts solely to preserve study assignment. The protocol will establish a predefined rescue pathway for unsuccessful vascular access.

If continuation of the assigned technique is considered clinically inappropriate, the treating clinician may discontinue the assigned workflow and perform the vascular-access procedure considered appropriate for the participant's clinical condition.

Crossover, rescue access, protocol deviations, and safety-related overrides will be documented and included in the study analysis where applicable.

Operator Training and Standardization

Clinicians participating in the ultrasound-guided arm will be required to meet protocol-defined training or competency criteria before independently performing study procedures.

Training may address:

Ultrasound system operation. Peripheral vessel identification. Differentiation of veins from arteries. Needle visualization. In-plane or out-of-plane ultrasound techniques. Catheter advancement. Confirmation of catheter placement. Infection-prevention procedures. Documentation requirements. Safety and adverse-event reporting.

Operator experience and training status may be retained as study variables because operator competency may influence procedural outcomes.

Data Collection

Research data may include demographic, clinical, procedural, device, ultrasound, outcome, safety, and follow-up information.

Participants will be assigned coded study identifiers to support confidentiality and data management. Direct identifiers will be handled according to the study's human-subject protection, privacy, and data-security procedures.

Where ultrasound images are retained for research purposes, image acquisition, storage, coding, access, and de-identification will be governed by the approved study protocol and applicable privacy requirements.

Statistical Objectives

The primary statistical analysis will compare first-attempt cannulation success between the ultrasound-guided and standard-access groups.

Secondary analyses may compare the groups with respect to:

Number of attempts. Procedure duration. Successful access within two attempts. Rescue procedures. Escalation of vascular access. Pain scores. Complications. Catheter survival. Patient satisfaction. Operator-reported outcomes.

Additional multivariable analyses may evaluate whether factors such as difficult-access classification, body mass index, vessel depth, vessel diameter, access site, catheter characteristics, and operator experience are associated with successful first-attempt cannulation.

The study is intended to determine whether a standardized ultrasound-guided vascular-access strategy improves procedural success and to characterize the clinical and anatomical factors that may help identify patients most likely to benefit from ultrasound-guided vascular access.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Truway Health, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 12 years or older.
  • Requires peripheral venous vascular access as part of clinically indicated care.
  • Considered medically appropriate for peripheral intravenous catheter placement.
  • Able to undergo either ultrasound-guided or standard peripheral vascular-access procedures according to the study protocol.
  • For participants age 18 years or older, able to provide informed consent or participate under another IRB-approved consent process.
  • For participants younger than 18 years, permission from a parent or legally authorized representative and participant assent will be obtained when required by the reviewing IRB and applicable regulations.
  • Vascular access is expected to be performed at an anatomical site suitable for peripheral venous catheterization.
  • Participants with or without difficult intravenous access may be enrolled.
  • Willing and able to complete protocol-required procedural assessments and follow-up when applicable.

Exclusion Criteria:

  • Immediate life-threatening or emergency circumstances in which study enrollment, consent, assent, parental permission, or randomization could delay medically necessary treatment.
  • Existing functional vascular access that eliminates the clinical need for a new peripheral intravenous catheter.
  • Clinical requirement for immediate central venous, intraosseous, midline, PICC, or other non-peripheral vascular access rather than peripheral cannulation.
  • Infection, significant burn injury, major trauma, vascular injury, or another condition at the proposed access site that makes peripheral cannulation inappropriate.
  • Known vascular abnormality or another clinical condition that, in the judgment of the treating clinician or investigator, makes either randomized vascular-access strategy inappropriate or unsafe.
  • Inability to undergo either study-assigned vascular-access approach.
  • For participants younger than 18 years, inability to satisfy applicable parental permission and assent requirements unless an IRB-approved exception applies.
  • Participation in another interventional study that, in the investigator's judgment, could materially interfere with assessment of vascular-access outcomes.
  • Any medical, procedural, or logistical circumstance in which participation could interfere with timely delivery of clinically necessary care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ultrasound-Guided Peripheral Vascular Access
Participants assigned to this arm will undergo clinically indicated peripheral vascular access using real-time ultrasound guidance. The operator will use ultrasound visualization to identify an appropriate peripheral vessel and guide needle and catheter placement according to the standardized TVA-2026 vascular-access workflow. Procedural characteristics, number of cannulation attempts, time to successful access, first-attempt success, complications, rescue procedures, and other protocol-defined outcomes will be recorded.
Procedure: Ultrasound-Guided Peripheral Vascular Access
Peripheral venous catheterization performed with real-time ultrasound guidance. The operator uses ultrasound imaging to identify and assess an appropriate peripheral vessel and to guide needle and catheter placement. The procedure will follow standardized study procedures and applicable clinical practice. Ultrasound findings and procedural variables may include vessel depth, vessel diameter, anatomical location, catheter characteristics, operator experience, number of attempts, procedure duration, and successful catheter placement.
Device: Point-of-Care Ultrasound System for Vascular Access Guidance
An FDA-cleared point-of-care B-mode ultrasound imaging system will be used in accordance with its cleared labeling to identify an appropriate peripheral vein, assess vessel depth and diameter, and provide real-time visualization during needle and peripheral intravenous catheter placement. The study evaluates ultrasound-guided vascular-access performance; no investigational modification of the ultrasound system is planned.
Active Comparator: Standard Peripheral Vascular Access
Participants assigned to this arm will undergo clinically indicated peripheral vascular access using conventional techniques, including visual inspection, palpation, anatomical landmarks, and standard vein-selection methods without initial real-time ultrasound guidance. If vascular access cannot be successfully obtained within protocol-defined limits, clinically appropriate rescue or escalation procedures may be used and documented.
Procedure: Standard Peripheral Vascular Access
Peripheral venous catheterization performed using conventional vascular-access techniques without initial real-time ultrasound guidance. Vessel selection may be based on visualization, palpation, anatomical landmarks, tourniquet-assisted assessment, and standard clinical judgment. Rescue ultrasound or another clinically appropriate vascular-access method may be used after protocol-defined unsuccessful attempts or whenever clinically necessary.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First-Attempt Peripheral Vascular Cannulation Success
Time Frame: During the initial vascular-access procedure, approximately 30 minutes or less.
Percentage of participants who achieve successful placement of a functional peripheral vascular catheter on the first cannulation attempt. First-attempt success is defined as successful catheter placement following the first skin puncture/needle insertion associated with the assigned vascular-access procedure, with confirmation of functional vascular access by blood return and/or successful saline flush without immediate evidence of infiltration or extravasation.
During the initial vascular-access procedure, approximately 30 minutes or less.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Successful Vascular Access Within Two Cannulation Attempts
Time Frame: During the initial vascular-access procedure, approximately 30 minutes or less.
Percentage of participants who achieve successful placement of a functional peripheral vascular catheter within two cannulation attempts using the initially assigned vascular-access strategy or protocol-defined rescue procedures.
During the initial vascular-access procedure, approximately 30 minutes or less.
Total Number of Cannulation Attempts
Time Frame: During the initial vascular-access procedure, approximately 30 minutes or less.
Total number of needle insertion attempts required to obtain successful functional peripheral vascular access. Each new skin puncture intended to obtain vascular access will be counted as one attempt.
During the initial vascular-access procedure, approximately 30 minutes or less.
Time to Successful Peripheral Vascular Access
Time Frame: During the initial vascular-access procedure, approximately 30 minutes or less.
Elapsed time, measured in minutes, from initiation of the assigned vascular-access procedure to confirmation of successful functional peripheral catheter placement.
During the initial vascular-access procedure, approximately 30 minutes or less.
Requirement for Rescue or Escalation of Vascular Access
Time Frame: From initiation of vascular access through completion of the initial access episode, approximately 60 minutes.
Percentage of participants requiring a protocol-defined rescue or escalation procedure after unsuccessful or clinically inappropriate continuation of the initially assigned vascular-access strategy. Rescue may include ultrasound guidance, assistance from another clinician, alternative anatomical access, midline placement, peripherally inserted central catheter placement, central venous access, or another clinically appropriate method.
From initiation of vascular access through completion of the initial access episode, approximately 60 minutes.
Patient-Reported Procedural Pain
Time Frame: Immediately following completion of the vascular-access procedure, approximately within 15 minutes.
Participant-reported pain associated with the vascular-access procedure measured using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.
Immediately following completion of the vascular-access procedure, approximately within 15 minutes.
Incidence of Vascular Access-Related Complications
Time Frame: From vascular-access placement through 72 hours after placement or catheter removal, whichever occurs first.
Percentage of participants experiencing one or more vascular-access-related complications, including hematoma, bleeding, infiltration, extravasation, accidental arterial puncture, phlebitis, local infection, catheter dislodgement, thrombosis, premature catheter failure, or another clinically significant access-related adverse event.
From vascular-access placement through 72 hours after placement or catheter removal, whichever occurs first.
Functional Catheter Survival
Time Frame: From successful catheter placement through 72 hours or catheter removal, whichever occurs first.
Duration of time that the initially successfully placed peripheral vascular catheter remains functional without unplanned removal, infiltration, occlusion, dislodgement, or other failure requiring replacement.
From successful catheter placement through 72 hours or catheter removal, whichever occurs first.
Patient Satisfaction With Vascular Access Procedure
Time Frame: Immediately following completion of the vascular-access procedure, approximately within 15 minutes.
Participant-reported satisfaction with the vascular-access experience assessed using a protocol-defined 5-point Likert scale ranging from 1, very dissatisfied, to 5, very satisfied.
Immediately following completion of the vascular-access procedure, approximately within 15 minutes.
Operator-Reported Procedural Difficulty
Time Frame: Immediately following completion of the vascular-access procedure, approximately within 15 minutes.
Clinician-reported difficulty of the vascular-access procedure assessed using a protocol-defined 5-point scale ranging from 1, very easy, to 5, very difficult.
Immediately following completion of the vascular-access procedure, approximately within 15 minutes.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Point-Biserial Correlation Between Vessel Depth and First-Attempt Cannulation Success
Time Frame: During the initial vascular-access procedure
Point-biserial correlation coefficient (rpb; unitless; possible range -1 to +1) between: (1) target-vessel depth, measured in millimeters from the skin surface to the anterior vessel wall using electronic calipers on B-mode ultrasound before needle insertion; and (2) first-attempt cannulation success, recorded as yes or no on the standardized case-report form according to the protocol-defined first-attempt success criteria. A higher positive coefficient indicates that greater vessel depth is associated with a higher probability of first-attempt success; a negative coefficient indicates an inverse relationship.
During the initial vascular-access procedure
Point-Biserial Correlation Between Vessel Diameter and First-Attempt Cannulation Success
Time Frame: During the initial vascular-access procedure
Point-biserial correlation coefficient (rpb; unitless; possible range -1 to +1) between: (1) target-vessel internal diameter, measured in millimeters using electronic calipers on B-mode ultrasound at the intended cannulation site before needle insertion; and (2) first-attempt cannulation success, recorded as yes or no on the standardized case-report form according to the protocol-defined first-attempt success criteria. A higher positive coefficient indicates that greater vessel diameter is associated with a higher probability of first-attempt success; a negative coefficient indicates an inverse relationship.
During the initial vascular-access procedure
First-Attempt Success Among Participants With Difficult Intravenous Access
Time Frame: During the initial vascular-access procedure, approximately 30 minutes or less.
Percentage of participants meeting protocol-defined difficult intravenous access criteria who achieve successful peripheral vascular catheter placement on the first cannulation attempt, compared between the ultrasound-guided and standard-access study groups.
During the initial vascular-access procedure, approximately 30 minutes or less.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Truway Health, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gavin C Solomon, M.D., Truway Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TWH-TVA-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported from TVA-2026 may be shared with qualified researchers following completion of the study and publication of the primary study results. Shared data may include participant characteristics, difficult intravenous access variables, randomized study assignment, procedural characteristics, vascular and ultrasound measurements, cannulation attempts, first-attempt success, procedure duration, rescue or escalation events, patient-reported outcomes, catheter outcomes, and protocol-defined safety data. Direct identifiers and information that could reasonably permit participant re-identification will not be shared. Data sharing will be subject to applicable informed-consent provisions, IRB requirements, privacy laws, data-use restrictions, and sponsor review.

IPD Sharing Time Frame

Beginning approximately 12 months after publication of the primary study results and remaining available for 5 years.

IPD Sharing Access Criteria

Qualified researchers affiliated with academic institutions, health care organizations, government agencies, or recognized research organizations may request access to de-identified individual participant data and supporting materials. Requests must include a scientifically sound research proposal, investigator credentials, institutional affiliation, intended analyses, data-security safeguards, and proposed publication or dissemination plans. Truway Health, Inc. will review requests for scientific merit, participant privacy, consent limitations, and regulatory compliance. Approved researchers may receive the de-identified IPD dataset, Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and analytic code, as applicable. A data-use agreement may be required. Recipients must not attempt participant re-identification or redistribute the data without authorization.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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