Magnet System Gastric Outlet Obstruction Study
ConditionGastric Outlet Obstruction
Trial statusNot yet recruiting
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 to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).
Eligibility criteria
Qualifiers
Gastric outlet obstruction (GOO) and indicated for a gastroenterostomy, per the discretion of the treating investigator.
If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study.
Willing and able to comply with protocol requirements and provides written informed consent to participate in the study.
Disqualifiers
Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the gastroenterostomy procedure.
Baseline Eastern Cooperative Oncology Group (ECOG) > 2 and/or Karnofsky Performance score < 30
Gastric or intestinal cancer or malignant infiltration precluding creation of a magnetic compression anastomosis (per investigator discretion)
Coagulation disorders, on continuous or complete anticoagulation, or other conditions associated with high risk of bleeding and not correctable or manageable, precluding creation of a magnetic compression anastomosis (per investigator discretion)
Trial design
Treatments tested in this trial
- Magnet System
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov