A RANDOMIZED, SUBJECT AND EVALUATOR-BLINDED, PARALLEL-GROUP, MULTICENTER CLINICAL TRIAL USING AN ENDOSCOPIC SUTURING DEVICE (G-CATH EZ™ SUTURE ANCHOR DELIVERY CATHETER) FOR PRIMARY WEIGHT LOSS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 377
- 试验地点
- 11
- 主要终点
- Total Body Weight Loss
研究概览
简要总结
This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled study intended to evaluate the safety and efficacy of treating obese patients with the placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as compared to a sham procedure followed by the same diet and exercise plan. Subjects will be randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or the sham procedure followed by diet and exercise. After un-blinding at 12 months post-treatment, sham patients can choose to have the treatment procedure as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Be male or female subjects between the ages of 22-60 years.
- •If female, be either post-menopausal, surgically sterile or agree to practice birth control during year of study and have negative serum HCG at screening and baseline.
- •Have a Body Mass Index (BMI) of ≥30 and <35 with at least one non-severe co-morbid obesity related condition or a BMI ≥ 35 and < 40 with or without a non-severe obesity related co-morbid condition, where a severe co-morbid condition is defined as severe if symptoms cause severe discomfort, performance of daily activities is compromised, and/or condition is not entirely controlled with prescription drug therapy.
- •Have had no significant weight change (+/- 5% of total body weight) in last 6 months.
- •Have an American Society Anesthesiologists-PS score ≤ 2 (Appendix III).
- •Agrees not to have any additional weight loss interventional procedures, liposuction, or take any over the counter or prescription weight loss medication for 24 months following study enrollment.
- •Have not taken any prescription or over the counter weight loss medications for at least 6 months and agrees not to utilize for 12 months following study enrollment.
- •Be willing to cooperate with post-operative dietary recommendations and assessment tests.
- •Reside within a reasonable distance from the Investigator's treating office (~50 miles) and able and willing to travel to the Investigator's office to complete all routine follow-up visits.
排除标准
- •History of (or intra-operative evidence of) prior bariatric, gastric or esophageal surgery.
- •Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments.
- •Severe gastro-esophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy.
- •Large hiatal hernia (>3 cm) by history or as determined by pre-randomization endoscopy.
- •Pancreatic insufficiency/disease.
- •Active gastric erosions or gastric/duodenal ulcer.
- •History of gastroparesis or symptoms that would be suggestive of gastroparesis.
- •Pregnancy or plans of pregnancy in the next 12 months.
- •Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 1 month of Visit
- •Intranasal/inhaled steroids are acceptable.
- •History of inflammatory disease of the GI tract; coagulation disorders; hepatic insufficiency or cirrhosis
- •History or present use of insulin or insulin derivatives for treatment of diabetes
- •Type II Diabetes Mellitus (as defined by HgbA1c >6.5%) for greater than 10 years at the time of enrollment
- •Quit smoking within the last 6 months at time of enrollment or plans to quit smoking in the year after enrollment
- •Portal hypertension and/or varices.
- •Gastric outlet obstruction or stenosis.
- •Significant abnormality identified during Visit 2 (randomization visit) with endoscopy revealing large hiatal hernia, gastric ulcer, gastric erosions, etc.
- •Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
- •Beck Depression Inventory (Short) Score ≥12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment.
- •Present or past history of psychosis, bipolar disease, or obsessive compulsive disorder after pre-enrollment history and medical /psychological assessment.
- •Non-ambulatory or has significant impairment of mobility.
- •Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.
- •Participating in another clinical study.
- •Is a relative of investigator or his/her staff, or is employed by investigator or institution involved in the study.
- •Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
研究组 & 干预措施
Treatment group
The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise
干预措施: placement of g-Cath EZ suture anchors (Device)
Treatment group
The treatment of obese patients with the placement of g-Cath EZ suture anchors along with Diet and Exercise
干预措施: Diet and Exercise (Behavioral)
Sham Group
The treatment of obese patients with the sham procedure along with Diet and Exercise
干预措施: Sham procedure (Procedure)
Sham Group
The treatment of obese patients with the sham procedure along with Diet and Exercise
干预措施: Diet and Exercise (Behavioral)
结局指标
主要结局
Total Body Weight Loss
时间窗: Enrollment to 12 months
Evaluate the effectiveness of the g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical, San Clemente, CA, USA) with diet and exercise as an early weight loss intervention for Class I obesity subjects with at least one non-severe obesity related co-morbid condition or Class II obesity subjects with or without a non-severe obesity related co-morbid condition compared to a sham procedure, diet and exercise group.
次要结局
- Quality of Life scores (IWQOL)(enrollment to 12 months)
- Comorbid status(Enrollment to 12 months)
- Eating Behavior changes(Enrollment to 12 months)