Magnet Anastomosis in Patients Undergoing Gastric Surgery (MAPS)

GI Windows

Status: Enrolling

Conditions: Gastric Anastomosis (Site)

Treatments: Device: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc

Study type: Interventional

Funder types: Industry

Identifiers

NCT06915337

GIW 25-002

Details and patient eligibility

About

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 gastro-jejunal anastomosis in participants undergoing gastric surgery.

Full description

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating gastric-jejunal anastomoses in patients undergoing gastric surgery.

Enrollment: 75 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 22 years or older at screening
2. Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal 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 300 kilometers 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 that would inhibit passing of SFM magnet
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 Participants with active H. pylori may continue with the screening process if they are treated via medication
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. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc

Experimental group

Description:

This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing gastric-jejunal anastomosis using the Flexagon SFM Device with OTOLoc.

Treatment:

Device: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc