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NCT06454916 · ClinicalTrials.gov registry record · NA

Functional Lumen Opening With Self-Forming Magnetic Anastomosis

A NA study, sponsored by GI Windows.

Completed
Registry status
NA
Development phase
79
Enrollment target

NCT06454916: Completed NA study, sponsored by GI Windows.

NCT06454916 is a NA study that has completed, run by GI Windows. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06454916, a NA study, has completed, sponsored by GI Windows.

COMPLETED
Registry status
NA
Development phase
79 participants
Enrollment target

Study Summary

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

Primary Outcome

The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.

Interventions

  • DEVICE Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2024-10-04
Est. Completion 2025-10-01
Phase NA
GI Windows

4 total trials

What the finished NCT06454916 record still lists

NCT06454916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc is the first listed.

NCT06454916 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06454916 about?

NCT06454916 is a clinical study titled "Functional Lumen Opening With Self-Forming Magnetic Anastomosis". The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

What is the current status of trial NCT06454916?

This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2024-10-04. Estimated completion is 2025-10-01.

What interventions are being tested in trial NCT06454916?

The interventions under investigation include: Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc (DEVICE).

Who is sponsoring clinical trial NCT06454916?

This trial is sponsored by GI Windows, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06454916's enrollment target sits among peer trials

79 1060th of 2000 higher than 941 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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Source: ClinicalTrials.gov NCT06454916, the US trial registry maintained by the National Library of Medicine. NCT06454916 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.