A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.

April 28, 2026 updated by: Renovo Concepts, Inc.
A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR®) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and require drainage for fluid removal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

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

Mechanical Tissue Resuscitation™ (MTR®) is intended for short-term (up to 7 days) use to externally drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy) for which a portion of the skull has been removed resulting in exposure of the dura/brain and require drainage of fluid.

This is a single arm early feasibility study. The study will comprise of patients who will receive MTR® therapy to remove fluid from the surgical site in patients that have undergone a craniotomy/craniectomy.

The patient population will include male and female patients ages 22-65 who have undergone a surgical procedure to remove a portion of the skull to expose the dura/brain (craniotomy or craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).

The study will be conducted in subsequent phases, to enroll patients in the following populations:

  • Phase 1: patients undergoing elective procedures;
  • Phase 2: patients with mild-to-moderate TBI, as defined by a GCS of 9 or above with two reactive pupils; and
  • Phase 3: patients with severe TBI, as defined by a GCS of 7 or 8 with two reactive pupils.

Patients will be treated with MTR® for up to seven (7) days, with a follow up evaluation approximately one month post treatment.

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.
11

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo Neurosurgery
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Phase 1:

  1. Patient is willing and able to provide written informed consent or has an appointed legally authorized representative (LAR) who can provide consent on the patient's behalf.
  2. The patient's age is ≥ 22 and ≤ 65 years.
  3. The patient has a clinical need for a craniotomy, craniectomy, or cranioplasty and for which, as an integral part of their care, a Jackson Pratt (JP) drain or equivalent would be placed at the surgical site.
  4. The surgical case is classified as 'clean'.

Phase 2:

  1. All Phase 1 criteria
  2. Patient has been diagnosed with a mild-to-moderate TBI with a GCS of 9 or above and has two reactive pupils.

Phase 3:

  1. All Phase 1 criteria
  2. Patient has suffered an acute, severe TBI with a GCS of 7-8 and has two reactive pupils.

Exclusion Criteria:

Phase 1:

  1. Patient has suffered an acute, severe traumatic brain injury, defined as less than 7 days since injury with GCS of less than 13.
  2. Patient is pregnant or lactating.
  3. Patient's BMI > 45
  4. Patient is participating in another clinical investigation.
  5. Patient's anticipated survival is < 48 hours.
  6. Patient is incarcerated at time of hospital admission.
  7. Patient has a coincidental infection.
  8. Patient has thrombocytopenia (platelet count < 150,000/µL).
  9. Patient has an International Normalized Ratio (INR) > 1.5.
  10. Patient is a known active opioid abuser at the time of surgery.
  11. Patient is a known active alcohol abuser at the time of surgery.
  12. Active bleeding at the site of surgery prior to placement of the device.

Phases 2 and 3:

1. Exclusion criteria 2-12 from Phase 1

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Mechanical Tissue Resuscitation™ (MTR®)
Device: Mechanical Tissue Resuscitation™ (MTR®)
Mechanical Tissue Resuscitation™ (MTR®) to drain excess fluid volume from the site of surgery in patients who have undergone a surgical procedure (craniotomy/craniectomy), or a procedure in which a portion of the skull has been repaired or replaced (cranioplasty), and who, as an integral part of their care would require placement of a Jackson Pratt drain (or equivalent).

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
Safety and effectiveness of MTR®
Time Frame: 30 days
The primary endpoint is to evaluate that MTR® is safe for the removal of fluids in those patients who have undergone a craniotomy/craniectomy/cranioplasty. This endpoint will be assessed by the frequency of device and procedure related adverse events.
30 days

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
AEs/SAEs Frequency
Time Frame: 30 days
Frequency of all adverse events experienced from the time of enrollment through study exit. Events will be categorized as adverse events (AEs) or serious adverse events (SAEs) and measured by site data entry review.
30 days
Ability to remove fluid
Time Frame: 7 days
Ability to remove fluid, measured volume of fluid and rate of removal.
7 days
Operator ease survey
Time Frame: 1 day (during day of surgery)

Operator survey measured by completion of the following 3 questions on the case report form for:

  1. ease of manifold placement,
  2. ease of exit tubing placement,
  3. ease of establishment of a vacuum seal.

Answered with a five category Likert scale ranging from Extremely Easy to Extremely Difficult.
1 day (during day of surgery)
Data Integrity
Time Frame: 30 days
Data integrity measured by the frequency of each type of missing data query seen during the course of the subject's treatment, and frequency of any other protocol deviation recorded during the study.
30 days
MTR® Success
Time Frame: 30 days

MTR® Success will be defined as:

  1. Placement: ability to establish and maintain pressure with adequate manifold sizing.
  2. Maintenance: lack of air leaks and evidence of fluid removal.
  3. Removal: ability to remove without tissue damage or excessive bleeding.
30 days
Health care professional (HCP) ease survey
Time Frame: 1 day (during day of surgery)

HCP survey regarding ease of system use/maintenance during treatment period.

Answered with a four category Likert scale ranging from Poor to Excellent for each specific category below:

  1. MTR Manifold (silicone foam) Sheet Placement
  2. Dome and Tubing Assembly Placement
  3. Use of Sub-Atmospheric Pressure Pump (SaPP®)
  4. Vacuum - Site closure
  5. Fluid Removal
1 day (during day of surgery)

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.
Renovo Concepts, Inc.

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 (Actual)

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.
November 1, 2024

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.
December 31, 2026

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.
December 31, 2026

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).
December 30, 2023

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.
December 30, 2023

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.
January 11, 2024

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.
May 4, 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.
April 28, 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.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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