Actively Recruiting
Magnet Anastomosis in Patients Undergoing Gastric Surgery
Led by GI Windows, Inc. · Updated on 2026-02-13
75
Participants Needed
2
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Magnet Anastomosis in Patients Undergoing Gastric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than IV at time of procedure
- Lives and intends to remain within 300 kilometers of study center for the study duration
- Able to refrain from smoking during study follow-up period
You will not qualify if you...
- Known or suspected allergy to silicone, nickel, titanium, or Nitinol
- Body Mass Index (BMI) greater than 55 kg/m2
- Uncontrolled diabetes with HbA1c greater than 10%
- Congenital or acquired abnormalities of the gastrointestinal tract that prevent passing the SFM magnet
- Diagnosed with obstructed or perforated colon cancer
- Conditions where endoscopy or laparoscopy is contraindicated or history of difficult or failed endoscopy
- Previous major surgery on stomach, duodenum, hepatobiliary tree (except laparoscopic gallbladder removal or prior sleeve gastrectomy), pancreas, or right colon
- Coagulation problems not corrected by treatment or platelet count below 50,000/µL
- Moderate to severe kidney disease or ongoing dialysis
- History of hyperkalemia, hypercoagulability, venous thromboembolism, or pulmonary embolism
- Immunocompromised status due to various causes including cancer treatment or high-dose corticosteroids
- Active H. pylori infection unless treated
- Active or suspected infection at the surgical site or contaminated/dirty infected wound
- Obstructive sleep apnea on CPAP unless cleared by independent physician
- Contraindication to general anesthesia
- Breastfeeding, pregnant, or planning pregnancy during follow-up
- Participation in another clinical trial within 30 days involving investigational drugs, devices, or biologics
- Deemed inappropriate for the trial by the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, Chile, 8580000
Not Yet Recruiting
2
Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh, India, 454555
Actively Recruiting
Research Team
P
Peter Lukin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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