Creating a temporary bowel connection with the GT Metabolic magnet system.

Creation of Compression Anastomosis Using the GT Metabolic Magnet System as Either the Primary or the First Stage of Colorectal Surgery (MagCR Study)

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

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: GT Metabolic Solutions, Inc. (industry)
• Locations: 1 site (Bergamo)
• Trial ID: NCT07431723 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Small series and device-specific reports of magnetic compression anastomosis have shown promising technical success, but larger controlled evidence is still limited.

Eligibility 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 this trial is running

Bergamo

• Policlinico San Marco, Bergamo — Bergamo, Italy (RECRUITING)

Study contacts

• Study coordinator: Lisa Griffin Vincent, PhD, MA

Conditions: Anastomosis, Functional, Colorectal, Magnet System, GT Metabolic Solutions, Inc.