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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05095935
Other study ID # Surgical PSR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 10, 2021
Est. completion date July 2025

Study information

Verified date June 2024
Source Medtronic
Contact PSR Study Team
Phone 1-800-633-8766
Email rs.productsurveillanceregistry@medtronic.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 340
Est. completion date July 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
N/A observational registry
N/A observational registry

Locations

Country Name City State
United States Cooper Health System Camden New Jersey
United States UNC Chapel Hill Chapel Hill North Carolina
United States Rush Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States Children's Hospital Colorado Denver Colorado
United States Duke University Health Systems Durham North Carolina
United States Mary Washington Hopital Fredericksburg Virginia
United States Cedars Sinai Medical Center Los Angeles California
United States UPMC Falk Clinic Pittsburgh Pennsylvania
United States University of Texas - San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of intraoperative hemostatic intervention 30 days
Secondary Incidence of repeat hospital admission for primary procedure-related complications 30 days
Secondary Intraoperative assessments: Assessment of staple line integrity using a five-point Likert scale Range from 1 (no bleeding) to 5 (significant bleeding requiring intervention) 30 days
Secondary Intraoperative assessments: Incidence of staple line bleeding (measured as > 50cc) 30 days
Secondary Intraoperative assessments: Additional intervention(s) to treat staple line failure 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) 30 days
Secondary Post-operative assessments: Additional intervention(s) to treat staple-line failure 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
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