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Recruiting
NCT06915337
Magnet Anastomosis in Patients Undergoing Gastric Surgery
Conditions: Gastric Anastomosis (Site)
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: GI Windows, Inc.
Location: Clinica Colonial Hospital Santiago Huechuraba, Región Metropolitana
Summary
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
Inclusion Criteria:
1. Aged 22 years or older at screening
2. Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent document
4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure
5. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
6. Able to refrain from smoking during study follow-up period
Exclusion Criteria:
1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
2. BMI \> 55 kg/m2
3. Uncontrolled diabetes (defined as HbA1c \>10%)
4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
5. Diagnosed with obstructed or perforated colon cancer
6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
8. Coagulation deficiency not normalized by medical treatment or platelet count \
Source: ClinicalTrials.gov (NCT06915337). StuddyBuddy aggregates publicly available trial information.