Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers

Study Overview
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Brief Summary
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The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon

Detailed Description
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The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 < BMI≤ 35.

Official Title
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Safety and Performance Evaluation of TrimWeight Device - an Intragastric Auto-inflating & Degradable Balloon in a Swallow-able Capsule (the Device), for Enhancing Satiety and Satiation in Healthy Over Weight and Obese Volunteers

Conditions
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Over Weight, Obesity

Intervention / Treatment
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* Device: Tulip capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 ≤ Age <65 years 30 < BMI ≤ 35 kg/m2 Healthy without any medication; No history of weight reduction of more than 5% of total body weight in the past 6 months; Normal blood count and chemistry; Hemoglobin level over 11; At least 3 bowel movements per week; Subject declares that he/she is able to go through gastroscopic examination; Subject is able and willing to give informed consent and follow protocol procedures. Exclusion Criteria: Any history or evidence of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results; History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit); History or symptoms of thyroid disease which is not controlled by medication; Abnormal gastrointestinal findings: Diaphragmatic hernia > 3 cm; Active peptic ulcer; Erosive gastritis; Gastric outlet obstruction; Subject with IBD Significant swallowing disorders; Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy); Malabsorption disorders. Is taking medications that reduce gastric acidity Currently using pharmaceutical agents or food supplements for weight loss; History of or current eating disorder such as anorexia or bulimia or compulsory overeating. History of food Allergy; Subject with poor venous access; Is taking chronic aspirin or other non-steroidal anti-inflammatory agents, or other medications known to be gastric irritants; Have any coagulation problem and/or taking any anticoagulant medications; Evidence of current malignant disease; Have history of any acute disease (viral, bacterial, pain, accident) in the last 6 weeks. Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study; Inability to give written informed consent; History of alcohol or drug abuse within 6 months of screening; Mental disorders; Currently participating in an ongoing clinical study Any reasons making the patient a poor candidate in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tulip capsule<br>swallowing Tulip capsule for up to 29 days | Device: Tulip capsule<br>* swallowing Tulip capsule for up to 29 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with device related serious adverse events | Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference. | 36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient assessment of capsule tolerability | Comfort and tolerability will be assessed by the patient and will be recorded in a daily diary. Tolerability evaluation will include: assessment of swallow ability, gastrointestinal comfort, defecation effort, appetite. | 36 days | 
| Satisfying evacuation of the balloon from the stomach after oral intake | Number of subjects showing satisfying evacuation of the balloon from the stomach after oral intake by means of a gastroscopic examination | 36 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Over weight, Obesity