Functional Lumen Opening With Self-Forming Magnetic Anastomosis

NCT06454916 | Completed DMC FDA Device

• 1 other identifier: GIW 24-001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 7

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 small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

Conditions

Small Bowel Anastomosis

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 the Flexagon SFM Device with OTOLoc

EXPERIMENTAL

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

Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc DEVICE

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.

Study Group: Prospective Evaluation of the 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 laparoscopic small bowel surgery requiring small bowel 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 185-mile 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
• 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
• 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 (7)

Fresno Community Hospital and Medical Center

Clovis, California, 93611, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Endeavor Health

Evanston, Illinois, 60201, United States

Location

Duke Regional Hospital

Durham, North Carolina, 27704, United States

Location

UT Health Houston

Houston, Texas, 77401, United States

Location

Seger Bariatrics and Metabolism, LLC

San Antonio, Texas, 78229, United States

Location

Study Officials

• Erik Wilson, MD

  The University of Texas Health Science Center, Houston

  STUDY CHAIR

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: June 6, 2024
• First Posted: June 12, 2024
• Study Start: October 4, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 1, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)