Status:
RECRUITING
Magnet Anastomosis in Patients Undergoing Gastric Surgery
Lead Sponsor:
GI Windows, Inc.
Conditions:
Gastric Anastomosis (Site)
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 ga...
Detailed Description
This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating gastric-jejunal anastomoses in patients unde...
Eligibility Criteria
Inclusion
- 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
- Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
- Able to refrain from smoking during study follow-up period
Exclusion
- 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
- Diagnosed with obstructed or perforated colon cancer
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
- Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
- Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
- Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
- Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
- Active H. pylori infection Participants with active H. pylori may continue with the screening process if they are treated via medication
- Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
- Contraindication to general anesthesia
- Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
- Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
- Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Key Trial Info
Start Date :
March 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06915337
Start Date
March 29 2025
End Date
March 1 2026
Last Update
November 13 2025
Active Locations (2)
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1
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, Chile, 8580000
2
Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh, India, 454555