Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
GI Windows, Inc.
Conditions:
Obesity, Morbid
Eligibility:
All Genders
18-65 years
Phase:
NA
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 w...
Detailed Description
This is a two-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a duodenal-ileal (D-I) anastomosis in participants who have experienced inad...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome
- For females of child-bearing potential: Pregnancy or desire to be pregnant during the study
- Concurrent condition anticipated to require MR imaging within the first 2 months after the study procedure
- Diagnosed Bulimia Nervosa or Binge Eating Disorder (using DSM-5 criteria)
- Physical or mental disability or psychological illness that in the opinion of the Investigator would be a contraindication for bariatric surgery
- Subject is 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.
- Subject has an active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator"
- Other prior or concurrent conditions that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives such as the presence/diagnosis of a severe and evolutive life threatening pathology unrelated to obesity including but not limited to: ongoing infection, chronic pancreatitis, severe hepatic dysfunction, or renal dysfunction (GFR \<60mL/min/1.73m2)
- Any form of substance abuse or psychiatric disorder that in the opinion of the investigator could interfere with the conduct of the study
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06200896
Start Date
December 12 2023
End Date
December 30 2025
Last Update
June 26 2025
Active Locations (1)
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1
Clínica Colonial Hospital
Santiago, Santiago Province, Chile, N-A