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CompletedNCT06454916FLOWSUpdated Nov 13, 2025

Functional Lumen Opening With Self-Forming Magnetic Anastomosis

An interventional study of Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc in Small Bowel Anastomosis, sponsored by GI Windows, Inc.. Completed at 7 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-11-13.

Sponsored by GI Windows, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 3 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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 small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

Read the 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.

02

Conditions studied

  • Small Bowel Anastomosis
03

In context

Lead sponsor

GI Windows, Inc. is the lead sponsor of 14 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • 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

Interventions

  • DeviceSmall 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.

06

What researchers measure

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.

    Time frame: 30 Days

07

Study locations

7 sites
  • Fresno Community Hospital and Medical Center
    Clovis, California 93611, United States
  • University of Miami
    Coral Gables, Florida 33146, United States
  • Orlando Health
    Orlando, Florida 32806, United States
  • Endeavor Health
    Evanston, Illinois 60201, United States
  • Duke Regional Hospital
    Durham, North Carolina 27704, United States
  • UT Health Houston
    Houston, Texas 77401, United States
  • Seger Bariatrics and Metabolism, LLC
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make IPD available.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06454916
Lead sponsor
GI Windows, Inc.
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Oct 4, 2024
Primary completion
Jun 30, 2025
Completion
Oct 1, 2025
Last update
Nov 13, 2025

Study contacts

Erik Wilson, MD
study chair · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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