Creation of Compression Anastomosis Using the GT Metabolic Magnet System (MagCR)

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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal; Anastomosis, Functional
• Intervention / Treatment: Device: Magnet System

Detailed Description

The objective of the MagCR Study is to evaluate the performance and safety of the Magnet System in eligible participants with colorectal disease as either primary or the first stage of surgical treatment. A magnetic compression anastomosis is fully reversable and may be considered for temporary staging of surgical treatments. Reversal of the compression anastomosis may be easily performed given the Magnet System leaves no foreign material behind (e.g., sutures or staples).

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josh Schumacher; Phone Number: +1 763-200-1416; Email: clinical@gtmetabolic.com
• Study Contact Backup: Name: Lisa Griffin Vincent, PhD, MA; Phone Number: +1 763-200-1416; Email: clinical@gtmetabolic.com

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Clinica MEDS La Dehesa SpA
    • Contact: Francisca Quintana; Phone Number: +56 22 9015945
    • Principal Investigator: James Hamilton, MD
• Italy
  • Bergamo, Italy
    • Recruiting
    • Policlinico San Marco, Bergamo
    • Principal Investigator: Stefano Olmi, MD
    • Sub-Investigator: Giovanni Cesana, MD
    • Contact: Sara Berva; Phone Number: +39 3317611886

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magnet System; GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")	Device: Magnet System; Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Natural Magnet Passage	Successful passage of magnets without surgical reintervention	90 days
Anastomosis Patency	Creation of a patent anastomosis confirmed radiologically.	90 days
Magnet Placement	Successful placement and connection of the Magnets	1 day

Collaborators and Investigators

• Sponsor: GT Metabolic Solutions, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Magnet System; GT Metabolic Solutions, Inc.
• Other Study ID Numbers: GTM-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No