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

NCT07495787 | Recruiting

• 1 other identifier: 2025/01/EDIT
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

English, Hindi and Gujarati

Conditions

Diabete Type 2

Keywords

Magnetic Compression Anastomosis

Outcome Measures

Primary Outcomes (1)

• Placement success rate - ≥ 90% alignment of magnets Passage of magnets without surgical re-intervention Safety

  evaluating Placement success rate Passage of magnets without surgical re-intervention Radiological confirmation of patent anastomosis Safety profile To monitor the safety profile of the device by assessing the incidence and severity of procedural and device related complications or adverse events

  Changes in glycosylated hemoglobin A1c (HbA1c) levels will be observed from baseline, 3 months, 6 months, 9 months and at 12 months following the index procedure.

Study Arms (1)

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Anastomosis

EXPERIMENTAL

Device: Magnetic Compression Anastomosis

Interventions

Magnetic Compression Anastomosis DEVICE

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).

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Anastomosis

Eligibility Criteria

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

You may qualify if:

• Subjects will be included in the study if they meet the following criteria:
• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged ≥ 25 years to ≤ 65 years.
• BMI greater than or equal to 25 and less than 50
• Clinical diagnosis of T2DM by plasma glucose criteria, either the fasting plasma glucose (FPG) value or the 2-h plasma glucose (2-h PG) value during a 75-g oral glucose tolerance test (OGTT), or A1C criteria
• Glycated Hemoglobin greater than or equal to 7.5% and less than 10.5% in at least one laboratory analysis conducted within the past 3 months, typically associated with a recommendation by patient's primary care physician and/or endocrinologist for intensification of treatment beyond oral medications
• Currently taking oral combination therapy for T2DM
• At least 12 months of experience with Diabetes Self-Management and Support

You may not qualify if:

• \. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months 2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.) 3. Current enrolment in another research study or previous participation within 30 days of enrolment 4. Current history of injected Glucagon Like Peptide 1 (GLP1) 5. American Society of Anesthesiologists (ASA) physical classification level of 4 or greater 6. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year) 7. 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 8. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 9. 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 10. History of small bowel surgery such as small bowel resection 11. Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.) 12. History of chronic or acute pancreatitis 13. Known active hepatitis or active liver disease 14. Symptomatic gallstones or kidney stones or acute cholecystitis
• Subjects will be deemed ineligible to participate if they fulfill any of the following criteria:
• 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
• Current history of injected Glucagon Like Peptide 1 (GLP1)
• American Society of Anesthesiologists (ASA) physical classification level of 4 or greater
• Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
• 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
• 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
• History of small bowel surgery such as small bowel resection
• Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.)
• History of chronic or acute pancreatitis
• Known active hepatitis or active liver disease

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 A 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: March 27, 2026
• Study Start: April 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)