NCT05559866已完成不适用
Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial (HAPCET): A Single-center Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Durability
研究概览
简要总结
This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) for weight loss and improvement in obesity-related co-morbidities compared to ESG alone in participants with a BMI ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 and ≤40 kg/m²
- •Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
- •History of failure with non-surgical weight-loss methods.
- •Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling.
- •Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow-up visits.
- •Ability to give informed consent.
- •Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
排除标准
- •History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy).
- •Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- •Prior open or laparoscopic bariatric surgery.
- •Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery.
- •Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as Crohn's disease or celiac disease.
- •Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
- •Gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes.
- •A gastric mass or gastric polyps > 1 cm in size.
- •A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
- •A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
- •Achalasia or any other severe esophageal motility disorder
- •Severe coagulopathy.
- •Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C≥
- •Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy.
- •Chronic abdominal pain.
- •Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation.
- •Hepatic insufficiency or cirrhosis.
- •Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
- •Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
- •Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.
- •Patients receiving daily prescribed treatment with high dose aspirin (> 81mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants.
- •Patients who are unable or unwilling to take prescribed proton pump inhibitor medication.
- •Patients who are pregnant or breast-feeding.
- •Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
- •Subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs.
- •Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications.
- •Subjects who are taking corticosteroids, immunosuppressants, and narcotics.
- •Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease.
- •Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer.
- •Diagnosis of autoimmune connective tissue disorder (e.g. Systemic lupus erythematosus, scleroderma) or immunocompromised.
- •Specific diagnosed genetic disorder such as Prader Willi syndrome.
- •Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- •Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
- •At the discretion of the PI for subject safety
- •If minority inclusion population target of 10% has not been reached by the 90% enrollment mark (example 21 of 24 subjects), the remaining enrollments will be reserved for minority subjects (example 3 of 24 subjects).
结局指标
主要结局
Durability
时间窗: 6 months
The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability.
Durability
时间窗: 6 months
The primary outcomes are durability of plications and endoscopic sutures on repeat endoscopy at 6 months, in the two randomized arms. Endoscopic scale runs from 0 to 3. A lower score indicates less durability and a higher score indicates greater durability.
次要结局
- Blood Pressure(6 month)
- Questionnaire: Eating Behavior(6 month)
- Percent Total Body Weight Loss (%TBWL)(6 month)
- Percent Excess Weight Loss (%EWL)(6 and 12 month)
- Blood Pressure(6 month)
- Percentage of Glycated Hemoglobin (% HbA1c)(6 month)
- Questionnaire: Short Form (36) Health Survey [SF-36](6 month)
- Questionnaire: Impact of Weight on Quality of Life (IWQOL)(6 month)
- Questionnaire: Patient Health Questionnaire-9 (PHQ-9)(6 month)
- Questionnaire: Eating Behavior(6 month)
- Binary Outcome: ≥25% Reduction in Percent Excess Weight Loss (%EWL)(6 month)
- Binary Outcome: Incidence of Esophagitis(6 month)
研究者
研究点 (2)
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