English, Hindi and Gujarati
Participants are willing and able to give informed consent for participation in the study.
Male or Female, aged ≥ 25 years to ≤ 65 years inclusive at the time of informed consent
BMI 30-50
Prior sleeve gastrectomy (> 12 months) or other metabolic surgical procedures with T2DM (characterized by HbA1c > 6.5%) or weight regain
Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months
Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
Current enrolment in another research study or previous participation within 30 days of enrolment
Use of injectable insulin
Single group
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion
DeviceThis 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
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
To evaluate feasibility of the magnetic compression anastomosis system in the development of partial jejunoileal diversion measured by evaluating Magnet placement success rate Passage of magnets without surgical re-intervention Radiological confirmation of patent anastomosis Primary feasibility endpoints will be met if the device performance is confirmed in more than 80 percent of treated safety
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