The BALLOON- (BALLOon Treatment for Obesity in Norway) Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adequate insertion
研究概览
简要总结
This protocol describes a feasibility pilot study preceding a randomized clinical study that aims at comparing the Elipse intragastric Balloon system to other invasive obesity techiniques.
The current pilot study is investigating the feasibility and efficacy of the Elipse Balloon system in 20 patients in Norway.
详细描述
The primary aims of the pilot study are to streamline the infrastructure, machinery, and clinical experience with the balloon before the start of the randomized trial. The inclusion and exclusion criteria, and measurement points will be similar for the two studies.
The primary endpoints of the pilot study are to ascertain the feasibility of
- Patient recruitment and informed consent process
- Balloon insertion procedure
- Follow-up of patients for the period of balloon therapy (one balloon)
- Data gathering, data management, and endpoint evaluation
- Adverse event evaluation of balloon insertion and therapy Secondary endpoints are weight loss, HBA1c
Eligible Patients Eligible patients are adults who have been referred for obesity treatment to one of the participating obesity centres and meet all of the inclusion criteria and none of the exclusion criteria.
Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 year or older with BMI ≥30 and ≤40 kg/m2, and a diagnosis of type 2 diabetes.
排除标准
- •Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
- •Previous bariatric or gastric surgery
- •History of chronic or acute pancreatitis
- •History of small bowel obstructions
- •History of open abdominal and/or pelvic surgery EXCLUDING open appendectomy with a right lower quadrant incision.
- •Thyroid or adrenal disease not controlled with medication
- •History of/or signs and/or symptoms of esophageal, gastric, or duodenal disease such as dysphagia and/or painful swallowing, hiatal hernias >5 centimeter, paraesophageal hernias, chronic or acute inflammation, cancer, varices, diverticula, gastroparesis, ulcers, stricture/stenosis, or achalasia
- •Specific diagnosed genetic or hormonal cause for obesity such as Prader-Willi syndrome
- •Severe coagulopathy, hepatic insufficiency or cirrhosis
- •Unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse deployment and continuing for 14 days after Elipse excretion
- •Anemia defined as either Hgb <11 g/dL for females and <12 g/dL for males
- •Inability to walk 200 meters without assistance
- •Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
- •Current or history of illicit drug use or excessive alcohol use
- •Currently taking the following medications (within 30 days prior to enrolment) and/or anticipated need for these medications during the study: Systemic corticosteroids; anticoagulants (e.g. warfarin, dabigatran) or anti-platelet therapy; narcotics or opiates; anti-seizure medication (e.g. clonazepam, phenytoin)
- •Serum autoantibodies against glutamic acid decarboxylase (GAD) or tyrosine phosphatase (IA2) (MODY or type 1 diabetes)
- •Any specified conditions that, in the opinion of the investigator, may render the subject unable to complete the study without a likely fatal outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data.
- •Women in childbearing age must document a negative pregnancy test. Women must not be breast-feeding at the time of treatment.
结局指标
主要结局
Adequate insertion
时间窗: 4 months
percentage of adequate balloon insertion and balloon excretion
次要结局
- weight loss(4 months)
研究者
Michael Bretthauer
Professor
Oslo University Hospital