Medtronic Signia SDR Product Surveillance Registry

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

• Study Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars Sinai Medical Center
  • Colorado
    • Denver, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper Health System
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC Chapel Hill
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Health Systems
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Falk Clinic
  • Texas
    • San Antonio, Texas, United States, 78249
      • Recruiting
      • University of Texas - San Antonio
  • Virginia
    • Fredericksburg, Virginia, United States, 22401
      • Recruiting
      • Mary Washington Hopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
Incidence of intraoperative hemostatic intervention	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Range from 1 (no bleeding) to 5 (significant bleeding requiring intervention)	30 days
Intraoperative assessments: Incidence of staple line bleeding (measured as > 50cc)		30 days
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
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

Collaborators and Investigators

• Sponsor: Medtronic

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 10, 2021
• Primary Completion (ANTICIPATED): April 1, 2025
• Study Completion (ANTICIPATED): July 1, 2025

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (ACTUAL): October 27, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID 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