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

NCT07350967 | Recruiting DMC

• 1 other identifier: 2025/08/EMMIT
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

English, Hindi and Gujarati

Conditions

Diabetes Type 2; Bariatric Surgery

Keywords

Magnetic Compression Anastomosis

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (1)

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion

EXPERIMENTAL

Device: Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion

Interventions

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion DEVICE

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

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• T2DM without a history of gastrectomy or other metabolic surgical procedures (diagnosis for \> 6M and \<10 yrs) taking at least oral antidiabetic medication with fasting glucose \< 200mg/dl and HbA1c \>6.5 %
• Agrees to abstain from any form of additional bariatric or reconstructive surgery that could influence body weight for a duration of 1 year

You may not qualify if:

• 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
• Uncontrolled T2DM
• Uncontrolled hypertension, dyslipidemia, or sleep apnea
• Current history of injected Glucagon Like Peptide 1 (GLP1)
• Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies
• History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging
• Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures
• Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures
• History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum
• Refractory gastroesophageal reflux disease (GERD)
• Barrett's esophagus
• Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques

Sponsors & Collaborators

• iIDEAS Group Holdings Limited: lead

Study Sites (1)

AB Plus Speciality Hospital

Ahmedabad, Gujarat, 380054, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Purvi Chavda, MD

CONTACT

8905818034; purvi@curexbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 20, 2026
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)