Using magnets to connect parts of the stomach during surgery
GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures
This study is testing a new way to connect parts of the stomach during surgery using magnets to see if it works safely and effectively for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | GI Windows, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Santiago, Huechuraba, Región Metropolitana and 1 other locations) |
| Trial ID | NCT06915337 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of the Flexagon Self Forming Magnet Anastomosis system combined with OTOLoc for creating gastro-jejunal anastomoses in patients undergoing gastric surgery. It is a prospective, multi-center, single-arm study that will assess how well this innovative approach works in facilitating the surgical connection between the stomach and the jejunum. Participants will be monitored for outcomes related to the procedure's success and any potential complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older who are scheduled for gastric surgery requiring a gastro-jejunal or gastro-ileal anastomosis.
Not a fit: Patients with a BMI over 55 kg/m2 or uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective gastric surgeries with improved recovery times for patients.
How similar studies have performed: While this approach is innovative, similar studies using magnet-assisted techniques have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 \<50,000/µL 9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis 10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism 11. 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 12. Active H. pylori infection Participants with active H. pylori may continue with the screening process if they are treated via medication 13. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound. 14. Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician 15. Contraindication to general anesthesia 16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period 17. 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 18. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Where this trial is running
Santiago, Huechuraba, Región Metropolitana and 1 other locations
- Clinica Colonial Hospital — Santiago, Huechuraba, Región Metropolitana, Chile (Not_yet_recruiting)
- Mohak Hitech Specialty Hospital — Indore, Madhya Pradesh, India (Recruiting)
Study contacts
- Principal investigator: Mohit Bhandari, MD — Bhandari Hospital & Research Centre
- Study coordinator: Peter Lukin
- Email: peter.lukin@giwindows.com
- Phone: +1 7814717901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.