Actively Recruiting
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
Led by iIDEAS Group Holdings Limited · Updated on 2026-01-20
5
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
English, Hindi and Gujarati
CONDITIONS
Official Title
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants willing and able to give informed consent
- Male or female aged 25 to 65 years inclusive
- Body mass index (BMI) between 30 and 50
- Prior sleeve gastrectomy (>12 months) or other metabolic surgery with T2DM (HbA1c > 6.5%) or weight regain
- T2DM diagnosis for more than 6 months and less than 10 years, taking at least oral antidiabetic medication with fasting glucose < 200 mg/dl and HbA1c > 6.5%
- Agreement to avoid any additional bariatric or reconstructive surgery affecting body weight for 1 year
You will not qualify if you...
- Pregnancy, breastfeeding, or planning pregnancy within 9-12 months
- Vulnerable individuals such as mentally or physically disabled, prisoners
- Current enrollment in another study or participation within past 30 days
- Use of injectable insulin
- Uncontrolled Type II Diabetes Mellitus
- Uncontrolled hypertension, dyslipidemia, or sleep apnea
- Current use of injected Glucagon Like Peptide 1 (GLP1)
- Evidence of type 1 diabetes or pancreatic exhaustion
- History of unusual or challenging gastrointestinal anatomy
- Previous intestinal, colonic, or duodenal surgery excluding bariatric procedures
- Prior surgeries, trauma, implants, diseases, or genetic factors hindering the procedure
- History or risk of Crohn's disease, inflammatory bowel disease, celiac disease, cancer resections, or intra-abdominal adhesive disease
- Refractory gastroesophageal reflux disease (GERD) or Barrett's esophagus
- Anatomical anomalies obstructing gastroscope access
- Presence of implantable pacemaker or defibrillator
- Any medical condition posing safety concerns for endoscopic or laparoscopic surgery
- History of small bowel surgery such as resection
- Active H. pylori infection unless treated and resolved
- History of pancreatitis
- Active liver disease or hepatitis
- Symptomatic gallstones, kidney stones, or acute cholecystitis
- History of coagulopathy or upper gastrointestinal bleeding conditions
- Use of anticoagulation therapy (excluding aspirin) that cannot be stopped
- Use of P2Y12 inhibitors that cannot be stopped
- Serious T2DM complications such as coronary artery disease or diabetic retinopathy
- Use of corticosteroids or drugs affecting gastrointestinal motility
- Use of weight loss medications
- Persistent anemia (hemoglobin <10 g/dL)
- Severe kidney impairment (eGFR <30 ml/min/1.73m2)
- Active systemic infection
- Recent cancer treatment or active malignancy
- Substance abuse or alcoholism
- Unhealed ulcers or lesions at magnet site
- Need for MRI within 2 months after procedure
- Anatomical anomalies preventing laparoscopic access
- Surgical or interventional procedures within 30 days before or planned within 30 days after procedure
- Recent stroke or transient ischemic attack
- Any condition or circumstance that might prevent completion of follow-up or affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AB Plus Speciality Hospital
Ahmedabad, Gujarat, India, 380054
Actively Recruiting
Research Team
P
Purvi Chavda, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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