NCT07495787

Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: iIDEAS Group Holdings Limited · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

English, Hindi and Gujarati

Detailed description

Title: Magnetic Compression Anastomosis Procedure for Partial Jejunoileal Anastomosis: Assessing the Viability of an Innovative Metabolic Approach Protocol Number 2025/01/EDIT Trial Type Investigator Initiated Trial This investigator-initiated trial (IIT) is a prospective, single-center, single-arm observation study in patients designed to explore metabolic indicator and procedural outcomes in patients with T2DM. A total of 5 patients with T2DM will be recruited in the study. Following the administration of general anesthesia, surgeon will introduce the ring component of the magnetic compression anastomosis system through an enterotomy. The insertion of the distal ring into the terminal ileum via an enterotomy, positioned approximately 30 cm proximal to the ileocecal valve, utilizing a laparoscopic deployment instrument. The proximal ring is then placed in the proximal jejunum, located around 20 cm (with a variance of ± 10 cm) distal to the ligament of Treitz. Laparoscopic techniques are 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). This IIT will be conducted in single centre in India by a qualified investigator. It will be initiated after Institutional Review Board (IRB)/Independent Ethics Committee (IEC). The anticipated timeline for this study is as follows: * Study Participant Enrollment: 02 months * Procedure Period: 01 day * Post procedure care: As suggested by the PI * Safety and functionality follow-up: 6 weeks, 3 months, 6 months, 9 months * Additional indications of efficacy follow-up: 12 months

Conditions

• Diabete Type 2

Interventions

Type	Name	Description
DEVICE	Magnetic Compression Anastomosis	This is an Investigator Initiated trial, prospective, single-center, single-arm observational study in patients with Type II Diabetes Mellitus (T2DM). A total of 5 patients with T2DM will be recruited in the study. Following the administration of general anesthesia, surgeon will introduce the ring component of the magnetic compression anastomosis system through an enterotomy. Laparoscopic techniques are 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).

Timeline

• Start date: 2025-04-22
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: India