Actively Recruiting
Creation of Compression Anastomosis Using the GT Metabolic Magnet System
Led by GT Metabolic Solutions, Inc. · Updated on 2026-02-25
50
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 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 of the study and agrees to comply with required testing, medications, follow-up visits, and has provided written informed consent.
You will not qualify if you...
- High frailty index with a score of 63 3 on the five-item modified frailty index (mFI-5)
- Severe sarcopenia as determined by the investigator
- Prior surgery, trauma, prostheses, disease, or genetic conditions preventing the procedure, including scarring or abnormal anatomy at the target sites
- Any anomaly preventing or contraindicating orogastric or colonoscopic access and procedures
- Implantable pacemaker, defibrillator, or other devices that may interfere with the Magnet System
- Psychiatric disorder except well-controlled depression with medication for more than 6 months
- Pregnant, lactating, or planning pregnancy during the study
- Comorbidities or physiological fitness concerns making participant medically unfit for the procedure
- Unhealed ulcers, bleeding lesions, tumor, or other lesions at the magnet deployment site
- Expected need for MRI within 2 months after the 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
- Requires chronic anticoagulation therapy except aspirin
- Active infections requiring antibiotics unless resolved before procedure
- Current tobacco or nicotine use or cessation within 3 months prior to consent
- Known allergies to device components or contrast media
- Comorbidities likely to limit life expectancy to 12 months or less
- Participation in another investigational drug or device study not yet complete
- Other anatomic, medical, social, or psychological conditions limiting participation or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Policlinico San Marco, Bergamo
Bergamo, Italy
Actively Recruiting
Research Team
L
Lisa Griffin Vincent, PhD, MA
CONTACT
J
Josh Schumacher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here