Medtronic Signia SDR Product Surveillance Registry

Completed

• Conditions: Minimally Invasive Surgical Procedures; Surgical Procedures, Operative
• Interventions: Other: N/A observational registry

• Registration Number: NCT05095935
• Lead Sponsor: Medtronic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-27
• Status Verified: 2024-10
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal Pediatric	N/A observational registry	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Thoracic Adult	N/A observational registry	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
Abdominal Adult	N/A observational registry	Use of Signia SDR for the transection of renal arteries and veins in adult patients.

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative hemostatic intervention	30 days

Secondary Outcome Measures

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

Trial Locations

Locations (10)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Children's Hospital Colorado; 🇺🇸 Denver, Colorado, United States

Rush; 🇺🇸 Chicago, Illinois, United States

Cooper Health System; 🇺🇸 Camden, New Jersey, United States

Duke University Health Systems; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Texas - San Antonio; 🇺🇸 San Antonio, Texas, United States

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

UPMC Falk Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States

Mary Washington Hopital; 🇺🇸 Fredericksburg, Virginia, United States