Magnet Anastomosis in Patients Undergoing Gastric Surgery

NCT06915337 | Recruiting FDA Device

• 1 other identifier: GIW 25-002
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 2

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 gastric surgery.

Conditions

Gastric Anastomosis (Site)

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Successful Anastomosis Creation without the Need for Reoperation

  The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.

  30 Days

Study Arms (1)

Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc

EXPERIMENTAL

This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing gastric-jejunal anastomosis using the Flexagon SFM Device with OTOLoc.

Device: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc

Interventions

Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc DEVICE

This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of jejunum. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed.

Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (2)

Clinica Colonial Hospital

Santiago, Huechuraba, Región Metropolitana, 8580000, Chile

NOT YET RECRUITING

Mohak Hitech Specialty Hospital

Indore, Madhya Pradesh, 454555, India

RECRUITING

Study Officials

• Mohit Bhandari, MD

  Bhandari Hospital & Research Centre

  PRINCIPAL INVESTIGATOR

• Pablo Marin, MD

  Clinica Colonial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lukin

CONTACT

+1 7814717901; peter.lukin@giwindows.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 8, 2025
• Study Start: March 29, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); CL (1)