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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: Completed NA study, sponsored by Standard Bariatrics.
NCT04347837 is a NA study that has completed, run by Standard Bariatrics. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
• Safety will be defined using descriptive statistics for device related adverse events in the study period.
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 |
What the finished NCT04347837 record still lists
NCT04347837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Titan SGS stapler is the first listed.
NCT04347837 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04347837's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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