Medtronic Signia SDR Product Surveillance Registry

Surgical Procedures, Operative Clinical Trial

Official title:

Medtronic Signia Small Diameter Reload Product Surveillance Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05095935
• Other study ID #: Surgical PSR
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Minimally Invasive Surgical Procedures
• Surgical Procedures, Operative

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