Intestinal disease Problem with the intestines
Conditions
Interventions
a minimum given this is an investigational protocol), taking place in an 
operating room under general anesthesia. each Magnet is introduced orally 
either by swallowing (proximal Magnet ONLY) or delivered via endoscope or 
colonoscope (see the IFU for procedure details). Final positioning of each 
Magnet to the intended anastomosis sites is completed using the magnetic 
Laparoscopic Positioning Device (LPD) and optional non-magnetic laparoscopy 
devices, to manipulate the Magnet to the intended positions and lift and move 
the intestines to connect the two Magnets. A retrieval device is included if 
retrieval or conversion to an enterotomy is required to position a Magnet. 
Mesenteric defect closure is at the discretion of the surgeon and performed per 
standard of care at the institution.
The Magnet System is intended for use in the creation of anastomoses in 
minimally invasive and laparoscopic surgery throughout the large bowl and 
Please refer to the Instructions for Use (IFU) for a description of the study 
surgical procedure.
Procedural steps referring to standard practice, such as preparation and 
closure of access sites and mesenteric defect, are not described in the study 
IFU and shall be conducted according to the standard practice applicable at the 
investigational site. During the procedure, participants will be continuously 
monitored clinically, hemodynamically, and electrocardiographically, as per 
site standard of care. 
The procedure is an inpatient procedure (one night required for observation at 
Sponsors
GT Metabolic Solutions, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Between 18-75 years of age, at the time of informed consent. 2. 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 end-to-end with ileostomy. 3. 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
Exclusion criteria: 1. High frailty index, with a score of >= 3 on the five-item modified frailty index (mFI-5). 2. Severe sarcopenia as determined by the investigator. 3. 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. 5. Any anomaly preventing / contraindicating colonoscopic or laparoscopic access and procedures. 6. Implantable pacemaker or defibrillator (and/or other devices that may be impacted by or interfere with the Magnet System). 7. Psychiatric disorder, except well-controlled depression with medication for > 6 months. 8. History of substance abuse. 9. Pregnant, lactating, or planning pregnancy during the clinical investigation. Note: Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). 10. 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. 11. Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment site. 12. Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure. 13. 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. 14. Any stroke / Transient Ischemic Attack (TIA) <= 6 months prior to consent. 15. Requires chronic anticoagulation therapy (except aspirin). 16. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure. 17. Current tobacco / nicotine product usage or recent product cessation <= 3 months prior to informed consent. 18. Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media. 19. Participants with comorbidities that are likely to result in a life expectancy<= 12 months. 20. Currently participating in an investigational drug or another device study that has not reached its primary endpoint: Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 21. A positive COVID-19 test prior to the study procedure in accordance with local COVID-19 protocol. 22. 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 resu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary and safety endpoints are (both primary study parameters): Performance of the magnet system. The anastomosis with the Magnet System will be considered feasible if it results in successful: - Placement and connection of the Magnets; and - Passage of magnets without surgical reintervention; and - Creation of a patent anastomosis confirmed radiologically. This endpoint/outcome will be met if the performance is confirmed in 80% of enrolled and treated participants. Safety defined as incidence of serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: - All-cause mortality - Intestinal perforation and/or peritonitis - Intestinal obstruction - Life-threatening bleeding - Incidence of device malfunctions The incidence of treatment emergent AEs and SAEs is a standard measure of the safety. The incidence of device malfunction informs about device reliability. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secundary study parameters. | — |
Countries
Italy, Netherlands, Spain
Contacts
Public ContactFrea Coun
Archer Research
Outcome results
None listed