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NCT03515811 · ClinicalTrials.gov registry record
A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
A clinical trial, sponsored by Medtronic - MITG.
- Completed
- Registry status
- 136
- Enrollment target
NCT03515811: Completed study, sponsored by Medtronic - MITG.
NCT03515811 is a clinical trial that has completed, run by Medtronic - MITG. The registered enrollment target is 136 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03515811 has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- 136 participants
- Enrollment target
Study Summary
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.
Primary Outcome
The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria: Led to a death, b. Led to a serious deterioration in the health of the subject, that either
Interventions
- DEVICE Signia™ Stapling System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2019-01-22 |
| Est. Completion | 2020-07-13 |
What the finished NCT03515811 record still lists
NCT03515811 is an observational study that tracks outcomes without assigning an intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Signia™ Stapling System is the first listed.
NCT03515811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03515811 about?
NCT03515811 is a clinical study titled "A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.". The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Techn...
What is the current status of trial NCT03515811?
This trial is currently completed. The enrollment target is 136 participants. The study started on 2019-01-22. Estimated completion is 2020-07-13.
What interventions are being tested in trial NCT03515811?
The interventions under investigation include: Signia™ Stapling System (DEVICE).
Who is sponsoring clinical trial NCT03515811?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
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