Magnet Anastomosis in Patients Undergoing Gastric Surgery
ConditionGastric Anastomosis (Site)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorGI Windows, Inc.
About this trial
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a gastro-jejunal anastomosis in participants undergoing gastric surgery.
Eligibility criteria
Qualifiers
Aged 22 years or older at screening
Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis with cardiac/medical clearance for surgery
Able to understand and sign informed consent document
American Society of Anesthesiologists (ASA) score < IV at time of procedure
Disqualifiers
Known or suspected allergy to silicone, nickel, titanium or Nitinol
BMI > 55 kg/m2
Uncontrolled diabetes (defined as HbA1c >10%)
Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
Trial design
Treatments tested in this trial
- Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov