Clinical trial NCT06454916: Functional Lumen Opening With Self-Forming Magnetic Anastomosis
Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Small Bowel Anastomoses in Patients Undergoing Surgical Procedures
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Small Bowel Anastomosis
Lead sponsor: GI Windows, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Clovis
country: United States
facility: Fresno Community Hospital and Medical Center
state: California
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Evanston
country: United States
facility: Endeavor Health
state: Illinois
city: Durham
country: United States
facility: Duke Regional Hospital
state: North Carolina
city: Houston
country: United States
facility: UT Health Houston
state: Texas
city: San Antonio
country: United States
facility: Seger Bariatrics and Metabolism, LLC
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Erik Wilson, MD
role: STUDY_CHAIR
References: