Medtronic Signia SDR Product Surveillance Registry

Medtronic

Status: Completed

Conditions: Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Treatments: Other: N/A observational registry

Study type: Observational

Funder types: Industry

Identifiers

NCT05095935

Surgical PSR

Details and patient eligibility

About

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.

Enrollment: 430 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

430 participants in 3 patient groups

Thoracic Adult

Description:

Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.

Treatment:

Other: N/A observational registry

Abdominal Adult

Description:

Use of Signia SDR for the transection of renal arteries and veins in adult patients.

Treatment:

Other: N/A observational registry

Abdominal Pediatric

Description:

Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.

Treatment:

Other: N/A observational registry