Actively Recruiting
Creation of Compression Anastomosis Using the GT Metabolic Magnet System as Either the Primary or the First Stage of Colorectal Surgery (MagCR Study)
Led by GT Metabolic Solutions, Inc. · Updated on 2026-05-19
50
Participants Needed
2
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance and safety of the GT Metabolic Magnet System for creating anastomoses in patients with colorectal disease. This device is studied as either the main surgical treatment or the first step in staged colorectal surgery. The magnetic compression anastomosis is reversible and does not leave foreign materials such as sutures or staples, making it suitable for temporary surgical staging. The study involves using the Magnet System to create connections within the large bowel or between the large bowel and distal small bowel. The procedure can be performed side-to-side or end-to-end along with ileostomy when required. The magnetic compression technique allows easy reversal of the anastomosis without leaving permanent materials behind. Participants will undergo magnet placement and be monitored for natural magnet passage and anastomosis patency up to 90 days after the procedure. The study includes various assessments such as follow-up visits and required testing to evaluate safety and device performance. The total participation duration depends on follow-up and testing requirements, ensuring careful monitoring throughout the study period.
CONDITIONS
Brief Title
Creation of Compression Anastomosis Using the GT Metabolic Magnet System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indicated for colorectal surgery requiring anastomosis within the colon or between colon and distal small bowel (colocolic, colorectal, rectalrectal, ileocolic, or ileorectal) performed side-to-side or end-to-end with ileostomy
- Participant has been informed about the study and agrees to its provisions
- Participant complies with required testing, medications, and follow-up visits
- Participant has provided written informed consent
You will not qualify if you...
- High frailty index with a score of 3 or higher on the modified frailty index (mFI-5)
- Severe sarcopenia as determined by the investigator
- Prior surgery, trauma, prostheses, disease, or genetic factors preventing the procedure including scarring or abnormal anatomy at target sites
- Any anomaly preventing or contraindicating colonoscopic or laparoscopic access or orogastric access
- Implantable pacemaker, defibrillator, or devices interfering with the Magnet System
- Psychiatric disorders except well-controlled depression with medication for over 6 months
- Pregnant, lactating, or planning pregnancy during the study
- Comorbidities or physiological fitness issues making participant medically unfit for the procedure
- Unhealed ulcers, bleeding lesions, tumors, or other lesions at the magnet deployment site
- Expected need for MRI within 2 months after procedure
- Any surgical or interventional procedure within 30 days before or after the study procedure
- Stroke or transient ischemic attack within 6 months prior to consent
- Requirement for chronic anticoagulation therapy except aspirin
- Active infections requiring antibiotics unless resolved before procedure
- Current tobacco or nicotine use or recent cessation within 3 months prior to consent
- Known allergies to device components or contrast media
- Comorbidities likely resulting in life expectancy less than 12 months
- Participation in another investigational drug or device study not yet completed
- Other medical, social, or psychological conditions limiting ability to participate or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 90 days
Participants undergo colorectal surgery involving magnetic compression anastomosis using the GT Metabolic Magnet System as either the primary or first stage of surgical treatment.
1 surgery visit and follow-up visits over 90 days
Trial Site Locations
Total: 2 locations
1
Clinica MEDS La Dehesa SpA
Santiago, Chile
Actively Recruiting
2
Policlinico San Marco, Bergamo
Bergamo, Italy
Actively Recruiting
Research Team
L
Lisa Griffin Vincent, PhD, MA
J
Josh Schumacher
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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