Functional Lumen Opening With Self-Forming Magnetic Anastomosis (NCT06454916) | Clinical Trial Compass
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 range
22 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is already completed, can you find out what the results showed — specifically how many patients had a successful anastomosis without needing a second operation, and whether those results might apply to my situation?
2This trial used self-forming magnetic devices to create a small bowel connection — how does that approach compare to the traditional surgical method you would use for me, and what are the known risks of each?
3Because this trial was listed as 'Phase NA,' it may not have followed the usual Phase 1-through-3 safety and efficacy pathway — what does that mean for how much we know about the long-term safety of this magnetic anastomosis technique?
4If the results from this trial are promising, is this magnetic anastomosis approach something that's available to me now, or is it still experimental and not yet part of standard care?
5Are there any published results or follow-up data from this trial that you could review with me, so we can decide together whether this technique might be worth considering over conventional surgery in my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
. 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