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Creation of Compression Anastomosis Using the GT Metabolic Magnet System

ConditionsAnastomosis, FunctionalColorectal
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Magnet System

    Device

    Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Magnet SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Magnet Placement

Successful placement and connection of the Magnets

Time frame
1 day
2

Natural Magnet Passage

Successful passage of magnets without surgical reintervention

Time frame
90 days
3

Anastomosis Patency

Creation of a patent anastomosis confirmed radiologically.

Time frame
90 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GT Metabolic Solutions, Inc.

Lead sponsor

Source ClinicalTrials.gov
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