CompletedNot Applicable

Functional Lumen Opening With Self-Forming Magnetic Anastomosis

United States79 participantsStarted 2024-10-04

Plain-language 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.

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 22 years or older at screening
✓. Candidate for laparoscopic small bowel surgery requiring small bowel anastomosis with cardiac/medical clearance for surgery
✓. Able to understand and sign informed consent document
✓. American Society of Anesthesiologists (ASA) score \< IV at time of procedure
✓. Lives, and intends to remain, within a 185-mile radius of study center for the duration of the study
✓. Able to refrain from smoking during study follow-up period

Exclusion criteria

✕. Known or suspected allergy to silicone, nickel, titanium or Nitinol
✕. BMI \> 55 kg/m2
✕. Uncontrolled diabetes (defined as HbA1c \>10%)
✕. Congenital or acquired anomalies of the GI tract, including atresia or malrotation
✕. Diagnosed with obstructed or perforated colon cancer
✕. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
✕. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
✕. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL

What they're measuring

Number of Participants with Successful Anastomosis Creation without the Need for Reoperation

Timeframe: 30 Days

Trial details

NCT IDNCT06454916

SponsorGI Windows, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Small Bowel Anastomosis trials