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Diabetes Type 22025/08/EMMITNCT07350967

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

A study testing Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion in people with Diabetes Type 2 and Bariatric Surgery, run by iIDEAS Group Holdings Limited at 1 site in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

English, Hindi and Gujarati Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Diabetes Type 2, Bariatric Surgery
What is being tested?
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteIndia
Study dates
11 Nov 2025to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • Presence of an implantable pacemaker or defibrillator
  • Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses any conditions for which endoscopic or laparoscopic surgery would be contraindicated, as well as any significant congenital or acquired anomalies of the gastrointestinal tract at or distal to the magnet placement site
  • Subjects will be deemed ineligible to participate if they fulfill any of the following criteria:
  • 1. 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. Use of injectable insulin 5. Uncontrolled T2DM 6. Uncontrolled hypertension, dyslipidemia, or sleep apnea 7. Current history of injected Glucagon Like Peptide 1 (GLP1) 8. 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 9. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 10. Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures 11. Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures 12. 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 13. Refractory gastroesophageal reflux disease (GERD) 14. Barrett's esophagus 15. Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques 16. Presence of an implantable pacemaker or defibrillator 17. Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses any conditions for which endoscopic or laparoscopic surgery would be contraindicated, as well as any significant congenital or acquired anomalies of the gastrointestinal tract at or distal to the magnet placement site 18. History of small bowel surgery such as small bowel resection 19. 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.) 20. History of chronic or acute pancreatitis 21. Known active hepatitis or active liver disease 22. Symptomatic gallstones or kidney stones or acute cholecystitis 23. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia 24. Use of anticoagulation therapy (excluding aspirin) which cannot be discontinued for 7 days before and 14 days after the procedure 25. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure (use of low-dose aspirin allowable) 26. History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and/or diabetes-related soft tissue infection 27. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide) 28. Receiving weight loss medications such as Meridia, Xenical, or over-the-counter weight loss medications 29. Persistent anemia, defined as Hgb<10 g dL-1 30. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) <30 ml/min/1.73m2 31. Active systemic infection 32. Chemotherapeutic cancer treatment within past 9 months, history of abdominal radiation, or active malignancy within the past 5 years 33. Active illicit substance abuse or alcoholism 34. Unhealed ulcers, bleeding lesions, tumors, or any other lesions at the target site for magnet deployment 35. Anticipated requirement for MR imaging within the first two months following the procedure 36. Any anatomical anomaly that prevents or contraindicates laparoscopic access and general laparoscopic procedures 37. Underwent a surgical or interventional procedure within 30 days prior to the current procedure 38. Any scheduled surgical or interventional procedure planned within 30 days following the current procedure 39. Any stroke or transient ischemic attack (TIA) within six months prior to obtaining consent 40. Any other serological markers likely to be associated with poor outcomes 41. Inability to adhere to the follow-up schedule and assessments 42. Any circumstance that, according to the investigator's judgment, could hinder the completion of follow-up evaluations up to Day 360 (for instance, a health issue that might elevate the risks linked to study involvement or could obstruct the analysis of study findings, failure to comply with the visit timetable, or inadequate adherence to the treatment protocol)
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Purvi Chavda, MD contact

8905818034

purvi@curexbio.com

India1 site, 1 recruiting

  • AB Plus Speciality Hospital

    Ahmedabad, Gujarat, 380054

    Purvi A Chavda, MD, 08905818034, purvi@curexbio.com

    Recruiting

Other trials in India

About this study

English, Hindi and Gujarati

Read the 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.

Being tested
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion
Keywords
Magnetic Compression Anastomosis
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal DiversionDevice

    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

Study groups in NCT07350967
Study groupRoleWhat they receive
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal DiversionExperimentalNot described
Receives: Device: Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start11 Nov 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07350967
Sponsor's protocol ID
2025/08/EMMIT
Acronym
2025/08/EMMIT
Status last verified
Jan 2026
First submitted
26 Dec 2025
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion in people with Diabetes Type 2 and Bariatric Surgery, run by iIDEAS Group Holdings Limited at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Purvi Chavda, MD (8905818034, purvi@curexbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07350967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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