Medtronic Signia SDR Product Surveillance Registry
Medtronic Signia Small Diameter Reload Product Surveillance Registry
1 other identifier
observational
430
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2021
CompletedFirst Submitted
Initial submission to the registry
August 24, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedResults Posted
Study results publicly available
January 7, 2026
CompletedJanuary 7, 2026
October 1, 2024
3.1 years
August 24, 2021
December 5, 2025
January 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Intraoperative Hemostatic Intervention
* 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 Outcomes (6)
Incidence of Repeat Hospital Admission for Primary Procedure-related Complications
30 days
Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale
During Procedure
Intraoperative Assessments: Incidence of Staple Line Bleeding
During Procedure
Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure
During Procedure
Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure
30 days
- +1 more secondary outcomes
Study Arms (3)
Thoracic Adult
Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
Abdominal Adult
Use of Signia SDR for the transection of renal arteries and veins in adult patients.
Abdominal Pediatric
Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Interventions
N/A observational registry
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (14)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Children's Hospital Colorado
Denver, Colorado, 80045, United States
The George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Rush
Chicago, Illinois, 60612, United States
Cooper Health System
Camden, New Jersey, 08103, United States
NYU Langone Medical Center
New York, New York, 10016, United States
New York Presbyterian Hospital - Colombia University Medical Center
New York, New York, 10032, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Health Systems
Durham, North Carolina, 27705, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
UPMC Falk Clinic
Pittsburgh, Pennsylvania, 15213, United States
University of Texas - San Antonio
San Antonio, Texas, 78249, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Mary Washington Hopital
Fredericksburg, Virginia, 22401, United States
Results Point of Contact
- Title
- Jennifer Bell
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2021
First Posted
October 27, 2021
Study Start
August 10, 2021
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
January 7, 2026
Results First Posted
January 7, 2026
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share