Incisionless Suture Plications in a POSE2.0 Interventional Randomized Obesity Study (The INSPIRO Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 186
- 主要终点
- Responder rate of at least 50% in the POSE2.0 treatment group
研究概览
简要总结
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (sutures placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
详细描述
This is a multi-center, open-label, 2-group randomized pivotal study evaluating a minimally invasive weight loss procedure. The intent is to evaluate the safety and effectiveness of POSE2.0 (g-Cath EZ Snowshoe Suture Anchors placed in the mid + distal body without placement in the fundus), with a moderate intensity diet and exercise program, as compared to diet and exercise alone. The procedure will be performed using the g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (AKA g-Cath or g-Cath EZ) and associated devices (g-Prox EZ, g-Lix and Transport), known collectively as the Incisionless Operating Platform (IOP).
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
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older 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 22-65 years.
- •History or failure with non-surgical weight-loss methods.
- •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 ≥ 30 and ≤ 50 kg/m².
- •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 to forego 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 in the last 6 months, with exception of medications used to manage T2D so long as the subject has been on a stable dose and weight has persisted.
- •Residing within a reasonable distance from the Investigator's treating office (~50 miles) and willing and able 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 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).
- •Patients who are known to be pregnant or breast-feeding, or plan to become pregnant in the next 12 months.
- •History of a known diagnosis or pre-existing symptom of rheumatoid arthritis, scleroderma, system lupus, or other autoimmune connective tissue disorder.
- •Immunosuppressive medications or systemic steroids (i.e., oral prednisone) within 6 months of Visit
- •Intranasal/inhaled steroids are acceptable.
- •Unable or unwilling to avoid use of aspirin and/or non-steroidal anti-inflammatory drugs (NSAIDs), or other medications known to be gastric irritants beginning two weeks prior to enrollment and throughout the entire study.
- •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, such as hemophilia.
- •History or present use of insulin or insulin derivatives for treatment of diabetes.
- •Patients with type II diabetes mellitus on oral agents (not injectables) with HgA1c > 9 at the time of enrollment.
- •Active smoker or someone who has been a smoker in the 6 months leading up to the study.
- •Portal hypertension and/or varices.
- •Patient has a history of drug or alcohol abuse or positive at screening for drug use.
- •Patient is currently using marijuana/cannabis for either medicinal or recreational use, or has plans to start using over the next 12 months.
- •Present or history of psychosis, bipolar disease, obsessive-compulsive disorder, binge eating, and/or other eating disorders 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.
- •Patient score >2 in any of the identified symptoms in the nausea/vomiting or bloating/distension domains on the Gastroparesis Cardinal Symptom Index (GCSI).
- •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).
- •Present or history of chronic abdominal pain.
- •Participating in another clinical study that could compromise compliance with the POSE2.0 study (must be cleared with investigator and USGI Medical).
- •Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to the drugs or materials that will be utilized in the study procedure.
- •Any other medical condition that would not permit elective endoscopy such as poor general health or history and/or symptoms of severe renal, hepatic, cardiac, and/or pulmonary disease, and/or physician's assessment that the subject is not an appropriate candidate.
研究组 & 干预措施
Treatment
POSE2.0 Treatment with Lifestyle Modification
干预措施: POSE2.0 procedure with g-Cath EZ Delivery Catheter with Snowshoe Suture Anchors (Device)
Control
Lifestyle Modification alone
结局指标
主要结局
Responder rate of at least 50% in the POSE2.0 treatment group
时间窗: 12 months
Responder defined as \>5% TBWL
Safety- Incidence of device and procedure related adverse events through 12 months
时间窗: 12 months
Incidence of device and procedure related adverse events through 12 months defined as Clavien-Dindo Class III or greater.
Percentage of total body weight loss (%TBWL) following randomization
时间窗: 12 months
To be deemed effective, the difference in %TBWL between the treatment group minus the control group must be significantly greater than 5%.
次要结局
未报告次要终点