RecruitingNot ApplicableNCT07350967

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy


Sponsor

iIDEAS Group Holdings Limited

Enrollment

5 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

English, Hindi and Gujarati


Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new endoscopic (non-surgical) procedure that uses small magnetic devices to create a shortcut connection in the small intestine, partially bypassing part of the gut. This is intended to treat type 2 diabetes and obesity — similar to bypass surgery but done through a scope with no large incisions. **You may be eligible if...** - You are 25–65 years old with a BMI of 30–50 - You have type 2 diabetes (diagnosed 6 months to 10 years ago) and are taking at least oral diabetes medication, OR - You previously had sleeve gastrectomy or another metabolic surgery and have experienced weight regain or ongoing type 2 diabetes - Your fasting blood sugar is below 200 mg/dL and your HbA1c is above 6.5% - You agree not to have other bariatric (weight loss) surgery for 1 year **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant within 9–12 months - You use injectable insulin or injectable GLP-1 medication - You have type 1 diabetes - You have uncontrolled high blood pressure, high cholesterol, or sleep apnea - You have a pacemaker or defibrillator - You have Crohn's disease, celiac disease, bowel cancer, or significant intestinal adhesions - You have serious diabetes complications (heart disease, kidney disease, retinopathy) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMagnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion

This is an Investigator Initiated, prospective, single-center, single-arm observational study evaluating feasibility and safety of novel magnetic compression Anastomosis device on the formation of partial jejunoileal diversion among obese patients with Type II Diabetes Mellitus (T2DM). A total of 5 patients will be recruited in the study. Following the administration of general anesthesia, an upper GI endoscope (iIDEAs EMMIT System) with the magnet will be maneuvered to the proximal jejunum. Following this, the snare catheter will release the distal magnet at the designated location, which is approximately 20 cm (± 10 cm) distal to the ligament of Treitz. Concurrently, the lower GI endoscope will be inserted into the terminal ileum through the ileocecal valve. The snare catheter will then assist in positioning the second magnet at the target area, located approximately 20 cm (± 10 cm) proximal to the ileocecal valve. Laparoscopic techniques will be employed


Locations(1)

AB Plus Speciality Hospital

Ahmedabad, Gujarat, India

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NCT07350967


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