NCT03721731已完成不适用
A Post-Market Surveillance Study Examining the Safety & Effectiveness of Using the g-Cath EZ Delivery Catheter With Snowshoe Suture Anchors and Associated Devices (g-Prox EZ, g-Lix and Transport) for the Treatment of Obesity
USGI Medical2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Mean % TBWL at 12 months
研究概览
简要总结
This is a multi-center, prospective study evaluating a treatment for obesity.
详细描述
This is a multi-center, prospective study evaluating a treatment for obesity using the g-Cath EZ and associated devices. The intent is to evaluate the safety and efficacy of a modified Snowshoe suture anchor placement pattern called Pose 2 (suture anchors placed in the mid + distal body of the stomach, with none placed in the fundus) along with a moderate intensity diet and exercise program. The g-Cath EZ and the associated devices (the g-Prox EZ, g-Lix & Transport) are known collectively as the Incisionless Operating Platform (IOP). Efficacy of the treatment will be evaluated based on changes in weight loss over 12 months, & adverse events will be recorded throughout the duration of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provision of signed and dated informed consent form
- •Subject agrees to be compliant with study requirements and adhere to post-operative dietary & exercise recommendations for the duration of the study.
- •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/baseline.
- •Have a Body Mass Index (BMI) of ≥ 35 and < 40 with one obesity related co-morbid condition (defined by 1991 NIH Guidelines with document referenced by FDA (Appropriateness Criteria for Bariatric Surgery: Beyond the NIH Guidelines)).
- •Pre-diabetes - Fasting plasma glucose test >100 mg/dl but ≤125 or oral glucose tolerance test ≥140 mg/dl but <
- •Diabetes - Individuals taking insulin and/or oral hypoglycemic medications or have a fasting glucose >126 mg/dl.
- •Hypertension - SBP>140 or DBP>90 or the use of an antihypertensive medication
- •Dyslipidemia - Triglycerides > 250 mg/dl or cholesterol > 220 mg/dl or HDL < 35 mg/dl or LDL > 200 or use of lipid lowering medications.
- •Sleep Apnea - A formal sleep study test consistent with this diagnosis; Epworth sleepiness scale ≥ 6; Polysomnography with respiratory disturbance index ≥ 10 hyponeic and/or apneic episodes per hour of sleep.
- •Venous Stasis Disease - Presence or history of pretibial venous stasis ulcers.
- •Chronic Joint Disease - Deterioration of joint cartilage and the formation of new bone (bone spurs) at the margins of the joints.
- •Quality of Life - Impaired quality of life is defined as poor quality of life as measured by a formal and previously validated quality of life (QOL) questionnaire (e.g. SF-12)
- •Gastroesophageal Reflux - Heartburn regurgitation or pain with swallowing and chest pain. Symptoms relieved by antacid medications.
- •Absence of current severe systemic disease (including, but not limited to: coronary artery disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, and chronic renal disease).
- •Agrees not to undergo any additional weight loss interventional procedures or liposuction for 12 months following study enrollment.
- •Have not taken any prescription or over the counter weight loss medications OR those that can suppress appetite/induce weight loss for at least 6 months and agrees not to utilize for 12 months following study enrollment (including all stimulant medication).
- •Subjects must be willing to possibly forego any future weight loss procedures (i.e. Vertical Sleeve Gastrectomy) given the unknown long-term effects.
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 endoluminal instruments or procedure execution.
- •Moderate 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 drug therapy.
- •Large hiatal hernia (>3 cm) by history or as determined by pre-enrollment endoscopy.
- •Pancreatic insufficiency/disease.
- •History of gastroparesis or symptoms that would be suggestive of gastroparesis or generalized dysmotility (e.g. esophago-gastric motility issues and lower esophageal sphincter abnormalities).
- •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.
- •Active gastric erosion, lesion, or gastric/duodenal ulcer.
- •History of or current platelet or coagulation dysfunction.
- •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 11 years at the time of enrollment.
- •If smoker, plans to quit smoking in the year after enrollment.
- •Portal hypertension and/or varices.
- •Patient has a history of drug or alcohol abuse or positive at screening for drugs of abuse.
- •Present or past history of psychosis, bipolar disease, or obsessive-compulsive disorder after pre-enrollment history and medical /psychological assessment.
- •Beck Depression Inventory (Short) Score ≥ 12 and/or uncontrolled depression after pre-enrollment psychological and medical assessment. 1
- •Non-ambulatory or has significant impairment of mobility (i.e. cannot ambulate for 30 minutes).
- •Known hormonal or genetic cause for obesity including untreated hypothyroidism (TSH >5.0 U/ml).
- •Participating in another clinical 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.
- •Physician's assessment that the subject is not an appropriate candidate. If significant findings for depression and/or suicidal ideation are identified, the psychologist(s) assigned to the study will be contacted and arrangement will be made for immediate intervention according to the Institution's standard procedure.
结局指标
主要结局
Mean % TBWL at 12 months
时间窗: 12 months
What is the Mean % TBWL for all Subjects at 12 months
Percentage of subjects with greater than/equal to 5% TBWL at 12 months
时间窗: 12 months
What % of subjects who have greater than/equal to 5% TBWL at 12 months
Incidence of Procedure/device related Adverse Events thru 12 months
时间窗: 12 months
Overall incidence of procedure/device related adverse events thru 12 months
次要结局
- Change from baseline in gastric emptying test results at 2 and 6 months(2 & 6 months)
研究者
研究点 (2)
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