Creation of Compression Anastomosis Using the GT Metabolic Magnet System

Official title

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

Overview

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

• Device Magnet System
  Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression.

Primary outcome measures

• Magnet Placement [Time frame: 1 day]
• Natural Magnet Passage [Time frame: 90 days]
• Anastomosis Patency [Time frame: 90 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Chile · 1 center

• Clinica MEDS La Dehesa SpA — Santiago

Italy · 1 center

• Policlinico San Marco, Bergamo — Bergamo

Identifiers

NCT: NCT07431723 · GTM-014

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗