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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COMPLETED
NA
26 participants
INTERVENTIONAL
2011-03-31
2014-04-30
Brief Summary
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Detailed Description
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Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.
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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vibrating capsule
Vibrant capsule
vibrating capsule
Interventions
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Vibrant capsule
vibrating capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception
Exclusion Criteria
* Patient must not use protocol-defined prohibited medicine
* History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
* Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
* Presents of pacemakers
* History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
* Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia.
* Actively participating in another clinical trial
18 Years
60 Years
ALL
Yes
Sponsors
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Vibrant Ltd.
INDUSTRY
Responsible Party
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Locations
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Tel Aviv Souraski medical Center
Tel Aviv, Israel, Israel
Barzilai MC
Ashkelon, , Israel
Italian Hospital
Nazeret, , Israel
Countries
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Other Identifiers
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Vibrant-09-MS-CTIL
Identifier Type: -
Identifier Source: org_study_id