Anastomosis, Functional, Colorectal
Conditions
Keywords
Magnet System, GT Metabolic Solutions, Inc.
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.
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).
Interventions
DEVICEMagnet System
Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression.
Sponsors
GT Metabolic Solutions, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Magnet Placement | 1 day | Successful placement and connection of the Magnets |
| Natural Magnet Passage | 90 days | Successful passage of magnets without surgical reintervention |
| Anastomosis Patency | 90 days | Creation of a patent anastomosis confirmed radiologically. |
Countries
Chile, Italy
Contacts
CONTACTLisa Griffin Vincent, PhD, MA
CONTACTJosh Schumacher
Outcome results
None listed