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NCT04347837 · ClinicalTrials.gov registry record · NA
Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
A NA study, sponsored by Standard Bariatrics.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT04347837 is a NA study that has completed, run by Standard Bariatrics. The registered enrollment target is 62 participants.
The verdict
NCT04347837, a NA study, has completed, sponsored by Standard Bariatrics.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
The Titan SGS stapler is the first minimally invasive stapler designed for the longitudinal resection of the stomach. This is the first experience using this stapler in humans. The purpose of this study is to demonstrate use of the Titan SGS stapler in creating longitudinal gastric resection. Safety is defined by the absence of device related adverse events in the study period. Usability is evaluated based on surgeon evaluation of the device following each use. This is a open label clinical trial to be conducted at three US sites. Up to 60 participants will be enrolled and will be followed for 6 weeks after surgery.
Interventions
- DEVICE Titan SGS stapler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-07-02 |
| Est. Completion | 2020-12-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04347837
The ClinicalTrials.gov registry entry for NCT04347837 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Standard Bariatrics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Titan SGS stapler is the first listed.
NCT04347837 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04347837 about?
NCT04347837 is a clinical study titled "Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection". The Titan SGS stapler is the first minimally invasive stapler designed for the longitudinal resection of the stomach. This is the first experience using this stapler in humans. The purpose of this study is to demonstrate use of the Titan SGS stapler in creating longitudinal gastric resection. Safety...
What is the current status of trial NCT04347837?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2020-07-02. Estimated completion is 2020-12-16.
What interventions are being tested in trial NCT04347837?
The interventions under investigation include: Titan SGS stapler (DEVICE).
Who is sponsoring clinical trial NCT04347837?
This trial is sponsored by Standard Bariatrics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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