Health TrialsbyHealthPanel

GT Metabolic Magnet System in Adults With Gastrointestinal Disorders

ConditionsGastric Outlet ObstructionSmall Bowel ObstructionSuperior Mesenteric Artery Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGT Metabolic Solutions, Inc.

About this trial

Evaluate the performance and safety of the GT Metabolic Magnet System for the creation of side-to-side compression anastomosis in the stomach and/or small bowel in conditions requiring an anastomosis as part of the underlying clinical treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Superior mesenteric artery syndrome (SMAS); OR

Gastric outlet obstruction (GOO); OR

Partial small bowel obstruction.

Meets the surgical clearance requirements as governed by the investigator's institution.

Disqualifiers

Other gastrointestinal or abdominal surgeries planned concurrently or within the study follow-up period (e.g., bariatric surgery such as sleeve gastrectomy).

Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the anastomosis or study procedure, including scarring and abnormal anatomy at the anastomosis sites.

Any anomaly precluding gastrointestinal access by gastroscope / endoscope, catheters, and associated manipulation techniques for device placement.

Any condition or disease that precludes laparoscopic surgery.

Trial design

Design model

Single group

Treatments tested in this trial

  • Magnet System

    Device

    Magnetic compression anastomoses for intestinal diversion in subjects with small bowel obstruction, gastric outlet obstruction, or superior mesenteric artery syndrome.

Treatment groups

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

Trial outcomes

Primary outcomes

1

Magnet Placement

Placement and connection of two intraluminal Magnet.

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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