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NCT05046730 · ClinicalTrials.gov registry record · NA
SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression
A NA study, sponsored by GI Windows.
- Terminated
- Registry status
- NA
- Development phase
- 128
- Enrollment target
NCT05046730: Clinical Trial NA study, sponsored by GI Windows.
NCT05046730 is a NA study that was terminated before completion, run by GI Windows. The registered enrollment target is 128 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05046730, a NA study, was terminated before completion, sponsored by GI Windows.
- TERMINATED
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
Study Summary
The objectives of this study are to determine the safety and effectiveness of the SFM Anastomosis Device when used to create a small bowel anastomosis for patients undergoing ileostomy reversal as compared with a propensity-matched historic control group of patients who underwent ileostomy reversal using a conventional closure technique (sutures or stapler).
Primary Outcome
The primary effectiveness hypothesis is that anastomosis success rate for the SFM device will be non-inferior to the anastomosis success rate observed for the propensity-matched historical control group
Interventions
- DEVICE Ileostomy Reversal using Self Forming Magnets (SFM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2023-12-30 |
| Phase | NA |
Why NCT05046730 stopped before completion
NCT05046730 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Ileostomy Reversal using Self Forming Magnets (SFM) is the first listed.
NCT05046730 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05046730 about?
NCT05046730 is a clinical study titled "SEAM Trial: Sutureless End to End Anastomosis by Magnetic Compression". The objectives of this study are to determine the safety and effectiveness of the SFM Anastomosis Device when used to create a small bowel anastomosis for patients undergoing ileostomy reversal as compared with a propensity-matched historic control group of patients who underwent ileostomy reversal ...
What is the current status of trial NCT05046730?
This trial is currently terminated. It is a NA study. The enrollment target is 128 participants. The study started on 2022-02-01. Estimated completion is 2023-12-30.
What interventions are being tested in trial NCT05046730?
The interventions under investigation include: Ileostomy Reversal using Self Forming Magnets (SFM) (DEVICE).
Who is sponsoring clinical trial NCT05046730?
This trial is sponsored by GI Windows, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05046730's enrollment target sits among peer trials
128 744th of 2000 higher than 1,252 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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