Medtronic Signia SDR Product Surveillance Registry

January 5, 2026 updated by: Medtronic

Medtronic Signia Small Diameter Reload Product Surveillance Registry

The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic, abdominal, and pediatric applications, intraoperatively.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Actual)

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.
430

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
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • Colorado
      • Denver, Colorado, United States, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • The George Washington University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Health System
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital - Colombia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill
      • Durham, North Carolina, United States, 27705
        • Duke University Health Systems
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Falk Clinic
    • Texas
      • San Antonio, Texas, United States, 78249
        • University of Texas - San Antonio
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Fredericksburg, Virginia, United States, 22401
        • Mary Washington Hopital

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

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgical procedures during which the Signia Small Diameter Reload is being used for transection of the arteries and veins meeting the cohort criteria.

Description

Inclusion Criteria:

  • Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
  • Patient has, or is intended to receive or be treated with, an eligible Medtronic product
  • Patient is consented within the enrollment window of the therapy received, as applicable

Exclusion Criteria:

  • Patient who is, or is expected to be, inaccessible for follow-up
  • Patient is excluded by local law
  • Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Thoracic Adult
Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
Other: N/A observational registry
N/A observational registry
Abdominal Adult
Use of Signia SDR for the transection of renal arteries and veins in adult patients.
Other: N/A observational registry
N/A observational registry
Abdominal Pediatric
Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Other: N/A observational registry
N/A observational registry

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
Incidence of Intraoperative Hemostatic Intervention
Time Frame: During Procedure
  • Adult Thoracic: incidence of intraoperative hemostatic intervention related to the transection of pulmonary arteries and veins.
  • Adult Abdominal: incidence of intraoperative hemostatic intervention related to the transection of renal arteries and veins.
  • Pediatric Abdominal: incidence of intraoperative hemostatic and leak intervention related to the transection of the appendiceal stump and mesoappendix (simple acute appendicitis).
During Procedure

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
Incidence of Repeat Hospital Admission for Primary Procedure-related Complications
Time Frame: 30 days
30 days
Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale
Time Frame: During Procedure
The Likert Scale assessment is a bleeding assessment that was conducted during the procedure, ranging from 1 (no bleeding) to 5 (significant bleeding requiring intervention). Staple line integrity was considered achieved for firings with a Likert Scale Score of 1, 2, 3 and 777 (not recorded at time of procedure, but deemed acceptable by the procedure surgeon).
During Procedure
Intraoperative Assessments: Incidence of Staple Line Bleeding
Time Frame: During Procedure
Number of firings that had an incidence of staple line bleeding of >50cc
During Procedure
Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure
Time Frame: During Procedure
Additional interoperative interventions to treat staple line failure (applying additional stapler reloads, applying compression greater than what is considered typical, over-sewing with suture, placing clips, use of energy, use of seatbelt, other)
During Procedure
Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure
Time Frame: 30 days
Additional postoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other)
30 days
Device Deficiencies
Time Frame: 30-days
incidence of subjects reporting device deficiencies affecting the intended performance of the device up to and including 30 days following the use of device (i.e. Signia™ Small Diameter Reloads) in surgery
30-days

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.
Medtronic

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.
August 10, 2021

Primary Completion (Actual)

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.
October 1, 2024

Study Completion (Actual)

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.
October 1, 2024

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, 2021

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.
October 25, 2021

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.
October 27, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
January 7, 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.
January 5, 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.
October 1, 2024

More Information

Terms related to this study

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.
  • Surgical PSR

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

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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