Recruiting nowNot phased
What this trial is trying to do
The researchers are testing whether the Flexagon self-forming magnet (SFM) system, used with OTOLoc, can join two sections of bowel after colon surgery by creating an anastomosis (a surgical connection) without the usual procedure for making that connection. The device is intended to form side-to-side or end-to-side bowel joins.
The trial asks whether this approach can create the planned connection without a related reoperation during the first 30 days. The comparison is with the standard surgical method, but there is no randomised control group, so the study mainly measures whether the device can be used successfully and safely.
Worth knowing: This is a small, non-randomised device study, and its main outcome is successful anastomosis without reoperation at 30 days rather than longer-term cancer control or survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07276529 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | open label |
| Taking part | 30 people (planned) |
| Who can join | aged 22 Years and over |
| Run by | GI Windows, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Device Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
What it is measuring
Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Aged 22 years or older at screening
2. Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent document
4. American Society of Anesthesiologists (ASA) score < IV at time of procedure
5. All cancer patients must have completed chemotherapy ≥1 months prior to procedure
6. Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study
7. Able to refrain from smoking during study follow-up period
Exclusion Criteria
1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
2. BMI > 55 kg/m2
3. Uncontrolled diabetes (defined as HbA1c >10%)
4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
5. Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
7. History of recurrent small bowel obstructions.
8. Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
9.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 2 sites. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07276529, registered by GI Windows, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.