Early Feasibility Study: Assessment of Self-Forming Magnetic Anastomosis Device and Delivery System (SFM) in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis

NCT06200896 | Active Not Recruiting

• 1 other identifier: GIW 23-004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 with patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SFM Anastomosis System to create a Jejuno-jejunostomy in Roux-en-Y gastric bypass procedures.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• Ability for physician to create a Magnet (SFM) Anastomosis

  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).

  2 days

• Safety of Creating a Magnet (SFM) Anastomosis

  "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

Study Arms (2)

SFM in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post Sleeve Gastrectomy

EXPERIMENTAL

Duodenal-Ileal Anastomosis Post Sleeve Gastrectomy created with Self Forming Magnets (SFM)

Device: Self Forming Magnets used to Create A Compression Anastomosis

SFM in Obese subjects when Used to Create a Jejuno-Jejunostomy (J-J) Anastomosis

EXPERIMENTAL

Jejuno-Jejunostomy (J-J) Anastomosis created with Self Forming Magnets (SFM) as part of a Roux-en-Y gastric bypass

Device: Self Forming Magnets used to Create A Compression Anastomosis

Interventions

Self Forming Magnets used to Create A Compression Anastomosis DEVICE

Self Forming Magnets used to Create A Compression Anastomosis connecting the Duodenum to the ileal in Post Sleeve Gastrectomy Patients and Jejunum to jejunum in Roux-en-Y patients.

SFM in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post Sleeve Gastrectomy; SFM in Obese subjects when Used to Create a Jejuno-Jejunostomy (J-J) Anastomosis

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years at screening
• For the post sleeve gastrectomy diversion procedures (SNAP-PS)- Obesity with Body Mass Index (BMI) ≥ 40 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) ≥ 35.1 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 24 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 24 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 atresias, 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 (1)

Clínica Colonial Hospital

Santiago, Santiago Province, N-A, Chile

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

• Juan Contreras, MD

  Head 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 29, 2023
• First Posted: January 11, 2024
• Study Start: December 12, 2023
• Primary Completion: January 12, 2025
• Study Completion: December 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)