Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)

NCT06199635 | Active Not Recruiting

• 1 other identifier: GIW 23-005
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 2

Brief Summary

The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure) or a Roux-en-Y gastric bypass jejuno-jejunostomy. Additionally, the study is designed to evaluate the potential of these procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint:

  Ability to create the anastomosis with SFM without the need for open conversion or use of additional laparoscopic/endoscopic anastomoses devices (endoscopic/laparoscopic suture devices or staplers - except for closure of the laparoscopic enterotomy).

  30 days

• Primary Safety Endpoint:

  The primary safety endpoint for this study is "Freedom from anastomosis adverse events" or "FFAAE" within 30 days including American College of Surgeons (ACS) Grade B/C anastomosis leak (requiring active therapeutic intervention/re-laparotomy), anastomotic bleeding, and small bowel obstruction. All adverse events will be documented.

  30 days

Secondary Outcomes (2)

• Total Body Weight Loss (TBWL)

  12 months

• Percent Responders

  12 Months

Study Arms (3)

SNAP-S

EXPERIMENTAL

Self-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Primary Sleeve Gastrectomy Duodenal-Ileal Anastomosis

Device: Self-Forming Magnetic Anastomosis Device and Delivery System

SNAP-PS

EXPERIMENTAL

Self-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Duodenal-ileal Anastomosis years after a Primary Sleeve Gastrectomy)

Device: Self-Forming Magnetic Anastomosis Device and Delivery System

J-J

EXPERIMENTAL

Self-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Jejuno-Jejunostomy in a Roux-en-Y Gastric Bypass

Device: Self-Forming Magnetic Anastomosis Device and Delivery System

Interventions

Self-Forming Magnetic Anastomosis Device and Delivery System DEVICE

Self-Forming Magnetic Anastomosis Device to create a gastrointestinal anastomosis

J-J; SNAP-PS; SNAP-S

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Subjects:
• Age 18-65 years at screening
• For the primary or post sleeve gastrectomy Anastomosis procedures (SNAP-S/SNAP-PS)- Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 but ≤ 55 kg/m2 at time of screening with or without comorbidities at time of screening. If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled
• For the Roux-en-Y gastric bypass jejuno-jejunostomy procedure (J-J) - Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 but ≤50 kg/m2 with or without comorbidities at time of screening. If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
• Able to understand and sign informed consent document
• Patient lives, and intends to remain, within a 150-km radius of study center for 12 months
• Willing to commit to sustained healthy behaviors that include diet, eating and exercise habits for the duration of the trial
• Willing to refrain from smoking during the study follow-up period
• If subject is female, she must commit to not becoming pregnant for 12 months and agree to use of contraceptives during this period and may not be nursing

You may not qualify if:

• \. Known or suspected allergy to nickel, titanium or Nitinol
• \. Type 1 Diabetes
• \. Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c \>10 or use of injectable insulin
• \. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
• \. Contraindication to general anesthesia
• \. Clinically significant finding during procedural endoscopy such as presence of an unhealed ulcers, bleeding lesions, tumors or ischemic or necrotic tissue at target magnet deployment site
• \. Congenital or acquired anomalies of the GI tract, including atresia, stenosis, prior obstruction or malrotation
• \. Presence of a duodenal diverticulum (\>10mm)
• \. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder), pancreas or right colon
• \. History of chronic gastrointestinal disease (e.g., cirrhosis, inflammatory bowel disease) that in the opinion of the Investigator may preclude safe and complete study participation
• \. Uncontrolled severe hypertension (blood pressure \>160/100mmHg)
• \. Pre-existing severe comorbid cardio-respiratory disease (e.g., congestive heart failure, uncontrolled cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease requiring supplemental oxygen, pulmonary embolism, Myocardial Infarction with prior 6 months)
• \. Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal
• \. Uncorrectable coagulation disorder (platelets \< 100,000, PT \>2 seconds above upper normal limit or INR \>1.5) at time of procedure, Note: management of anti-platelet medications, when applicable, will follow standard practices of the institution
• \. Uncorrectable anemia (Hemoglobin \< 11 g/dL in women and \<12.5 g/dL in men)

Sponsors & Collaborators

• GI Windows, Inc.: lead

Study Sites (2)

Clinica Colonial Hospital

Santiago, Huechuraba, Región Metropolitana, 8580000, Chile

Location

Bhandari Hospital & Research Centre

Indore, Madhya Pradesh, 452010, India

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohit Bhandari, MD

  Chief of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: December 15, 2023
• Primary Completion: January 15, 2025
• Study Completion: March 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); IN (1)