Creating a temporary bowel connection with the GT Metabolic magnet system.
Official title: Creation of Compression Anastomosis Using the GT Metabolic Magnet System as Either the Primary or the First Stage of Colorectal Surgery (MagCR Study)
Run by GT Metabolic Solutions, Inc. · NCT07431723 · Data updated 2026-11-12
This trial will test if the GT Metabolic Magnet System can safely create temporary bowel connections for people needing colorectal or ileocolic anastomoses.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | GT Metabolic Solutions, Inc. Industry-sponsored |
| Locations | 4 sites (Santiago and 3 other locations) |
| Status | Recruiting |
| Started | February 16, 2026 |
| Main results expected | March 2027 |
| Study ends | February 2028 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07431723 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults scheduled for colorectal or ileocolic anastomosis who can undergo colonoscopic or laparoscopic access and who do not have high frailty or severe sarcopenia.
✕Probably not a fit
Patients with high frailty (mFI-5 ≥ 3), severe sarcopenia, prior anatomy or scarring that prevents safe access, or other contraindications to colonoscopic or laparoscopic procedures are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The MagCR approach uses paired magnetic devices delivered via colonoscopic or laparoscopic techniques to compress tissue and form a temporary anastomosis between segments of the large bowel or between the large and distal small bowel. The compression anastomosis is designed to be reversible and to leave no permanent sutures or staples behind, with magnets removed or expelled after formation. Eligible participants are patients undergoing side-to-side or end-to-end colocolic, colorectal, rectal-rectal, ileocolic, or ileorectal anastomoses and able to tolerate endoscopic and laparoscopic access. The study tracks device performance and safety outcomes including anastomotic integrity, device-related complications, and need for additional intervention.
Why it matters
Potential benefit: If successful, this could offer a reversible, stapler-free bowel connection that leaves no permanent foreign material and may simplify temporary surgical staging.
How similar studies have gone: Small series and device-specific reports of magnetic compression anastomosis have shown promising technical success, but larger controlled evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indicated for colorectal surgery requiring anastomosis within the colon or colon and distal small bowel (i.e., colocolic, colorectal, rectalrectal, ileocolic, or ileorectal) performed side-to-side or endto-end with ileostomy * Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent. Exclusion Criteria: * High frailty index, with a score of ≥ 3 on the five-item modified frailty index (mFI-5). * Severe Sarcopenia as determined by the investigator. * Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy at the target anastomosis sites. * Any anomaly precluding orogastric access by colonoscope and catheters, and manipulation techniques. * Any anomaly preventing / contraindicating colonoscopic or laparoscopic access and procedures. * Implantable pacemaker or defibrillator (and/or other devices that may be impacted by or interfere with the Magnet System). * Psychiatric disorder, except well-controlled depression with medication for \> 6 months. * Pregnant, lactating, or planning pregnancy during the clinical investigation. * Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the Magnets. * Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment site. * Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure. * Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure. * Any stroke/Transient Ischemic Attack (TIA) ≤ 6 months prior to consent. * Requires chronic anticoagulation therapy (except aspirin). * Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure. * Current tobacco / nicotine product usage or recent product cessation ≤ 3 months prior to informed consent. * Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media. * Participants with comorbidities that are likely to result in a life expectancy ≤ 12 months. * Currently participating in an investigational drug or another device study that has not reached its primary endpoint * Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Where it's running
-
Clinica MEDS La Dehesa SpA
Santiago, Chile Recruiting -
Policlinico San Marco, Bergamo
Bergamo, Italy Recruiting -
Ospedale Evangelco Betania
Naples, Italy Recruiting -
Hospital Clinico San Carlos
Madrid, Spain Recruiting
Study contacts
- Study coordinator: Lisa Griffin Vincent, PhD, MA
- Email: clinical@gtmetabolic.com
- Phone: +1 763-200-1416
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.