NCT07350967招募中不适用
Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy
iIDEAS Group Holdings Limited0 个研究点目标入组 5 人开始时间: 2025年11月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
English, Hindi and Gujarati
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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
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: 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
- •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
- •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
- •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
- •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<10 g dL-1
- •Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) <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
- 另有 10 项未显示
研究者
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