Creation of Compression Anastomosis Using the GT Metabolic Magnet System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGT Metabolic Solutions, Inc.
About this trial
Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Magnet System
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov