Creation of Compression Anastomosis Using the GT Metabolic Magnet System

NCT07431723 | Recruiting DMC

• 1 other identifier: GTM-014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel.

Conditions

Anastomosis, Functional; Colorectal

Keywords

Magnet System; GT Metabolic Solutions, Inc.

Outcome Measures

Primary Outcomes (3)

• Magnet Placement

  Successful placement and connection of the Magnets

  1 day

• Natural Magnet Passage

  Successful passage of magnets without surgical reintervention

  90 days

• Anastomosis Patency

  Creation of a patent anastomosis confirmed radiologically.

  90 days

Study Arms (1)

Magnet System

EXPERIMENTAL

GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")

Device: Magnet System

Interventions

Magnet System DEVICE

Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression.

Magnet System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GT Metabolic Solutions, Inc.: lead

Study Sites (1)

Policlinico San Marco, Bergamo

Bergamo, Italy

RECRUITING

Central Study Contacts

Lisa Griffin Vincent, PhD, MA

CONTACT

+1 763-200-1416; clinical@gtmetabolic.com

Josh Schumacher

CONTACT

+1 763-200-1416; clinical@gtmetabolic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A 2-stage, open-label, multicenter study enrolling up to 60 subjects at up to 6 study centers in Europe and South America: * Stage 1: First-in-human (FIH) and proof-of-concept with up to 5 evaluable subjects; and * Stage 2: Feasibility with a goal of up to 45 evaluable subjects There will be a pause after completing enrollment and follow up to Day 30 for all Stage 1 subjects, with evaluation of safety by the independent Data Safety Monitoring Board (DSMB) to determine ability to move to the subsequent. \*Note: Evaluable subjects are enrolled subjects (signed ICF) who successfully undergo the study procedure. The total of 60 allows for attrition to hit the study goal of 50 evaluable subjects.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)