MAPSNCT06915337
Magnet Anastomosis in Patients Undergoing Gastric Surgery
StatusActive, Not Recruiting
PhaseNot applicable
SponsorGI Windows, Inc.
Primary completion (estimated)
At risk: Primary completion moved at least 5 months later.
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Record History
All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗
Notable Eligibility criteria expanded, about 24 words Show 4 more changesShow less
- Enrollment closed, study ongoing
- Primary completion pushed from Aug 2026 to Jan 31, 2027
- Study completion pushed from Dec 2026 to Feb 28, 2027
- Site details revised at 2 of 2 sites
- Minor Primary completion pushed from May 2026 to Aug 2026
- Study completion pushed from Jun 2026 to Dec 2026
- Minor Primary completion date: Dec 2025 to May 2026
- Study completion date: Mar 2026 to Jun 2026
- Minor Enrollment target: 56 to 75
- Study sites: 1 to 2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
Timeframe: 30 Days
Arms and interventions
Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLocExperimental
This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing gastric-jejunal anastomosis using the Flexagon SFM Device with OTOLoc.
Devices: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc
Sites
2 sites in 2 countries
Chile 1, India 1