Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
NCT ID: NCT01753609
Last Updated: 2012-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
8 participants
INTERVENTIONAL
2013-01-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tulip capsule
swallowing Tulip capsule for up to 29 days
Tulip capsule
swallowing Tulip capsule for up to 29 days
Interventions
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Tulip capsule
swallowing Tulip capsule for up to 29 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
65 Years
ALL
Yes
Sponsors
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Tulip Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sigal Fishman, Dr.
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Medical Center
Locations
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Tel Aviv Sourasky Medical Center , Gastroenterology - Institute
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Sigal Fishman, Dr.
Role: primary
Sara Pel
Role: backup
Other Identifiers
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TULIP-PRT-002-05-B-CTIL
Identifier Type: -
Identifier Source: org_study_id