Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:50 AM
Study NCT ID:
NCT07350967
Status:
RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
Official Title:
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2025/08/EMMIT
Brief Summary:
English, Hindi and Gujarati
Detailed Description:
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 to maneuver the bowel, aligning the proximal and distal magnets for effective magnetic coupling and observing the ring pair mating via intraoperative imaging (fluoroscopy or plain x-ray). An examination of Duodenum will be conducted for visualization of Duodenal Papilla. The gastroplasty, or other concomitant metabolic surgical procedure, will be conducted in accordance with the standard surgical protocol established by the hospital.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: