Clinical trial NCT01753609: Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Over Weight
Obesity
Keywords: Over weight
Obesity
Lead sponsor: Tulip Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with device related serious adverse events
timeFrame: 36 days
Secondary outcomes:
measure: Patient assessment of capsule tolerability
timeFrame: 36 days
measure: Satisfying evacuation of the balloon from the stomach after oral intake
timeFrame: 36 days
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center , Gastroenterology - Institute
Study officials:
affiliation: Tel Aviv Medical Center
name: Sigal Fishman, Dr.
role: PRINCIPAL_INVESTIGATOR
References: