Trials / Completed
CompletedNCT04347837
Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Standard Bariatrics · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Titan SGS stapler | Stapler for the longitudinal resection of the stomach |
Timeline
- Start date
- 2020-07-02
- Primary completion
- 2020-12-16
- Completion
- 2020-12-16
- First posted
- 2020-04-15
- Last updated
- 2021-03-22
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04347837. Inclusion in this directory is not an endorsement.