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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 is a clinical trial that has completed, run by Medtronic - MITG. The registered enrollment target is 136 participants.
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.
Interventions
- DEVICE Signia™ Stapling System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2019-01-22 |
| Est. Completion | 2020-07-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03515811
The ClinicalTrials.gov registry entry for NCT03515811 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic - MITG, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Signia™ Stapling System is the first listed.
NCT03515811 reports 0 study locations.
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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