Functional Lumen Opening With Self-Forming Magnetic Anastomosis

NCT ID: NCT06454916

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2025-10-01

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.

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.

Conditions

Small Bowel Anastomosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GI Windows, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Wilson, MD

Role: STUDY_CHAIR

The University of Texas Health Science Center, Houston

Locations

Fresno Community Hospital and Medical Center

Clovis, California, United States

University of Miami

Coral Gables, Florida, United States

Orlando Health

Orlando, Florida, United States

Endeavor Health

Evanston, Illinois, United States

Duke Regional Hospital

Durham, North Carolina, United States

UT Health Houston

Houston, Texas, United States

Seger Bariatrics and Metabolism, LLC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

GIW 24-001

Identifier Type: -

Identifier Source: org_study_id