A Postmarket Study for Continuing Evaluation and Periodic Reporting of the Safety and Effectiveness of the Spatz3 Intragastric Balloon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 537
- 试验地点
- 22
- 主要终点
- Serious Adverse Events (SAEs)
研究概览
简要总结
A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program.
The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.
详细描述
The purpose of the study is to demonstrate that the safety of the device in the postmarket setting is comparable to what was observed in the US pivotal study and to more accurately determine the rates of certain serious adverse events so that this information can be used to inform patient labeling.
Subjects in the open label, multi-center study will receive dietary/exercise counseling plus the Spatz3 Adjustable Balloon System for 32 weeks.
Eligible subjects will undergo endoscopy and those without endoscopic contraindications will be implanted with the Spatz3 Adjustable Balloon System for 32 weeks. All subjects will follow a 1000-1200 kcal/day-deficit diet during their participation in the study.
At 18 weeks ±4 weeks, subjects will be evaluated, and those that meet the criteria will undergo an adjustment procedure wherein the balloon volume will be increased to achieve extra weight loss. The balloon adjustment procedure is done with an endoscopy procedure under the same sedation as the implantation procedure.
At the end of the 32-week treatment period, all subjects who lost at least 5% Total Body Weight Loss (TBWL) prior to device removal will be followed for an additional 6 months. In addition, patients with device- and/or procedure-related adverse events will be followed until resolution of the event
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 22 - 65
- •BMI ≥ 35 and <40 kg/m2 or BMI of 30 to 34.9 kg/m2 with one or more major obesity- related comorbid conditions
- •Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
- •History of obesity (BMI ≥ 30) for at least 2 years
- •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, 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. Acceptable birth control methods are limited to hormonal contraceptives (oral, flexible vaginal ring, skin patch, injection), diaphragms, IUDs, condoms with or without spermicide, and voluntary abstinence. Should a treatment arm subject become pregnant during the implantation period, the balloon will be extracted during the second trimester - the timing of which will be determined via consultation with the subject's obstetrician.
排除标准
- •Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery.
- •Prior open or laparoscopic bariatric surgery.
- •Prior surgery of any kind on the esophagus, stomach, duodenum or any type of hiatal hernia surgery.
- •Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's 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.
- •A gastric mass.
- •A hiatal hernia > 2cm or severe or intractable gastro-esophageal reflux symptoms.
- •Acid reflux symptoms to any degree that require more than one medication for symptom control.
- •A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the balloon alongside the endoscope.
- •Achalasia or any other severe esophageal motility disorder that may pose a safety risk during the removal of the device
- •Severe coagulopathy.
- •Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months.
- •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
- •Serious or uncontrolled psychiatric illness or disorder that could compromise patient understanding of or compliance with follow up visits and removal of the device after 8 months.
- •Alcoholism or drug addiction.
- •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 aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants.
- •Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
- •Patients who are known to have, or suspected to have, an allergic reaction to materials contained in the system.
- •Patients who have BOTH:
- •A previous history of a serotonin syndrome AND
- •currently taking any drug known to affect the levels of serotonin in the body [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)].
- •Patients who are pregnant or breast-feeding.
- •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 who have tested positive for H. Pylori, and who have not yet been treated.
- •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
- •Subjects who are taking diet pills
- •Use of an intragastric device prior to this study due to the potential increase in risk associated with implantation of a balloon in a previously instrumented and possibly scarred stomach.
- •Participation in any clinical study which could affect weight loss within the past 6 months due to the potential to confound findings.
- •Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- •Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- •Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
- •Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator because of an increased risk profile.
- •Specific diagnosed genetic or hormonal cause for obesity such as untreated hypothyroidism or Prader Willi syndrome
- •Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
- •Known history of endocrine disorders affecting weight
结局指标
主要结局
Serious Adverse Events (SAEs)
时间窗: 32 weeks
The primary study endpoint is to demonstrate that the rate of device or procedure related SAEs is less than 8% at 8 months
次要结局
- Mean %TBL and percent excess weight loss (EWL%)(56 weeks)
- Percentage of Total Body Weight Loss (%TBWL)(32 weeks)