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

iEMIS HK Limited1 个研究点分布在 1 个国家目标入组 5 人开始时间: 2025年11月26日最近更新: 2025年11月21日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 5
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

研究设计

研究类型: Observational

入排标准

年龄范围: 25.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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 (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 %
•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.

排除标准

•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: Crohns disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckels diverticulum
•Refractory gastroesophageal reflux disease (GERD)
•Barretts 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
•History of small bowel surgery such as small bowel resection
•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
•Symptomatic gallstones or kidney stones or acute cholecystitis
•History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
•Use of anticoagulation therapy (excluding aspirin) which cannot be discontinued for 7 days before and 14 days after the procedure
•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)
•History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and/or diabetes-related soft tissue infection
•Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
•Receiving weight loss medications such as Meridia, Xenical, or over-the-counter weight loss medications
•Persistent anemia, defined as Hgb less than 10 g dL-1
•Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) less than 30 ml/min/1.73m2
•Active systemic infection
•Chemotherapeutic cancer treatment within past 9 months, history of abdominal radiation, or active malignancy within the past 5 years
•Active illicit substance abuse or alcoholism
•Unhealed ulcers, bleeding lesions, tumors, or any other lesions at the target site for magnet deployment
•Anticipated requirement for MR imaging within the first two months following the procedure
•Any anatomical anomaly that prevents or contraindicates laparoscopic access and general laparoscopic procedures
•Underwent a surgical or interventional procedure within 30 days prior to the current procedure
•Any scheduled surgical or interventional procedure planned within 30 days following the current procedure
•Any stroke or transient ischemic attack (TIA) within six months prior to obtaining consent
•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).

研究者

发起方

iEMIS HK Limited

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

主要研究者

Dr Mahendra Narwaria

AB Plus super speciality Hospital

研究点 (1)

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