Medtronic Signia SDR Product Surveillance Registry

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-10

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Minimally Invasive Surgical Procedures Surgical Procedures, Operative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Thoracic Adult

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

N/A observational registry

Intervention Type OTHER

N/A observational registry

Abdominal Adult

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

N/A observational registry

Intervention Type OTHER

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.

N/A observational registry

Intervention Type OTHER

N/A observational registry

Interventions

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N/A observational registry

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No