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CTRI Number  CTRI/2025/11/097889 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   NA 
Study Design  Single Arm Study 
Public Title of Study   Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion Assessing the Viability of an Innovative Metabolic Approach 
Scientific Title of Study   "Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy" 
Trial Acronym  2025/08/EMMIT 
Secondary IDs if Any  
Secondary ID  Identifier 
2025/08/EMMIT Version 01 Dated 26 August 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahendra Narwaria 
Designation  Bariatric Gastrointestinal and Robotic Surgeon 
Affiliation  AB Plus super speciality Hospital  
Address  Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India
Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India
Ahmadabad
GUJARAT
380054
India 
Phone  8905818034  
Fax    
Email  narwaria@yahoo.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Mahendra Narwaria 
Designation  Bariatric Gastrointestinal and Robotic Surgeon 
Affiliation  AB Plus super speciality Hospital  
Address  Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India
Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India
Ahmadabad
GUJARAT
380054
India 
Phone  8905818034  
Fax    
Email  narwaria@yahoo.com   
 
Details of Contact Person
Public Query  
Name  Dr Mahendra Narwaria 
Designation  Bariatric Gastrointestinal and Robotic Surgeon 
Affiliation  AB Plus super speciality Hospital  
Address  Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India
Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India
Ahmadabad
GUJARAT
380054
India 
Phone  8905818034  
Fax    
Email  narwaria@yahoo.com   
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  iEMIS HK Limited  
Address  iEMIS (HK) Limited iIDEAS Group Holdings Limited & iEMIS (HK) Limited Unit 4, 9/F Sun Cheong Industrial Building No 1 Cheung Shun Street, Lai Chi Kok Hong Kong SAR 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mahendra Narwaria  AB Plus Speciality Hospital  Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India Block V Mondeal Business Park Thaltej Ahmadabad GUJARAT 380054 India
Ahmadabad
GUJARAT 		 08905818034

narwaria@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KKMH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (2) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants are willing and able to give informed consent for participation in the study.
2. Male or Female, aged 25 years to 65 years inclusive at the time of informed consent
3. BMI 30-50
• Prior sleeve gastrectomy (more than 12 months) or other metabolic surgical procedures with T2DM (characterized by HbA1c more than 6.5%) or weight regain
• T2DM without a history of gastrectomy or other metabolic surgical procedures (diagnosis for more than 6M and less than 10 yrs) taking at least oral antidiabetic medication with fasting glucose less than 200mg/dl and HbA1c greater than 6.5 %
4. Agrees to abstain from any form of additional bariatric or reconstructive surgery that could influence body weight for a duration of 1 year
5.Able to comply with protocol requirements
 
 
ExclusionCriteria 
Details  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: Crohns disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckels diverticulum
13. Refractory gastroesophageal reflux disease (GERD)
14. Barretts 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 less than 10 g dL-1
30. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) less than 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 investigators 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) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Feasibility and performance evaluated by the success of the partial jejuno-ileal diversion

2. Safety Profile
 		 1. Feasibility and performance evaluated by the success of the partial jejuno-ileal diversion procedure

2. Safety Profile

 
 
Secondary Outcome  
Outcome  TimePoints 
1 Weight loss
Efficacy in terms of weight loss based on the change from baseline in total weight loss (Percent TWL) & excess weight loss (Percent EWL) to be assessed at 3 months, 6 months, 9 months & at 12 months following the index procedure
2 Metabolic Improvements
To observe changes in glycosylated hemoglobin A1c levels & blood glucose at the baseline with the HbA1c levels measured at 3 months, 6 months, 9 months & at 12 months following the index procedure 		 be assessed at 3 months, 6 months, 9 months & at 12 months following the index procedure 
 
Target Sample Size   Total Sample Size="5"
Sample Size from India="5" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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. The trial will be conducted in India with a qualified investigator. It will be initiated after Institutional Review Board (IRB)/Independent Ethics Committee (IEC).


 
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