Functional Lumen Opening With Self-Forming Magnetic Anastomosis (FLOWS)

GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Small Bowel 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 small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

Study Overview

• Status: Completed
• Conditions: Small Bowel Anastomosis
• Intervention / Treatment: Device: Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc

Detailed Description

This is a multicenter, pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Clovis, California, United States, 93611
      • Fresno Community Hospital and Medical Center
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Endeavor Health
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke Regional Hospital
  • Texas
    • Houston, Texas, United States, 77401
      • UT Health Houston
    • San Antonio, Texas, United States, 78229
      • Seger Bariatrics and Metabolism, LLC

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 laparoscopic small bowel surgery requiring small bowel 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 185-mile 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
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
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. Subject 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 the Flexagon SFM Device with OTOLoc; This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for a minimum of 70 subjects undergoing small bowel anastomosis using the Flexagon SFM Device with OTOLoc.

Device: Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc; This study will investigate one type of intervention: small bowel anastomosis creation in subjects undergoing laparoscopic small bowel surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically into two different sections of small bowel that are intended to be anastomosed. An OTOLoc device will be deployed into the small bowel wall in one section of the small bowel to provide access for the deployment of a Flexagon SFM into that section of bowel. The process is repeated at the second section of bowel. 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 sections of bowel 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: Study Chair: Erik Wilson, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GIW 24-001

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.: No