Magnet Anastomosis in Patients Undergoing Gastric Surgery (MAPS)

GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Anastomosis (Site)
• Intervention / Treatment: Device: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc

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 undergoing gastric surgery.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Lukin; Phone Number: +1 7814717901; Email: peter.lukin@giwindows.com

Study Locations

• Chile
  • Huechuraba, Región Metropolitana
    • Santiago, Huechuraba, Región Metropolitana, Chile, 8580000
      • Not yet recruiting
      • Clínica Colonial Hospital
      • Contact: Pablo Marin, MD; Phone Number: +56982947291; Email: doctorpablomarin@gmail.com
      • Contact: Francesca Gorziglia, MD; Phone Number: +56985007583; Email: francesca.gorziglia@gmail.com
• India
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 454555
      • Recruiting
      • Mohak Hitech Specialty Hospital
      • Principal Investigator: Mohit Bhandari, MD
      • Contact: Mohit Bhandari; Phone Number: (+91) 7314231753

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GI Windows, Inc.
• Investigators: Principal Investigator: Mohit Bhandari, MD, Bhandari Hospital & Research Centre; Principal Investigator: Pablo Marin, MD, Clínica Colonial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GIW 25-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes