Safety Evaluation of the Vibrating Capsule (Vibrant)
This study has been completed.
Information provided by (Responsible Party):
First received: February 21, 2011
Last updated: December 9, 2014
Last verified: December 2014
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
Device: Vibrant capsule
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
Primary Outcome Measures:
- Number of patients with adverse events [ Time Frame: 7.5 weeks of treatment period ] [ Designated as safety issue: Yes ]
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
Secondary Outcome Measures:
- Change in spontaneous bowel movement per week compared to baseline [ Time Frame: 9.5 weeks ] [ Designated as safety issue: No ]
Efficacy will be assessed by increase of more than one complete spontaneous bowel movement per week during the 7.5 weeks of treatment compared to 2 weeks baseline
- Patient assessment of capsule tolerability [ Time Frame: 7.5 weeks of treatment period ] [ Designated as safety issue: No ]
Comfort and tolerability will be assessed by the patient. Tolerability evaluation will include: assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
Experimental: vibrating capsule
Device: Vibrant capsule
Other Name: Vibrant
Healthy volunteers will be followed for safety for 7 days after taking the capsule.
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.
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients age 18-60 years
- 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
- Patient with Diverticulosis
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01306448
|AShkelon, Israel |
|Nazeret, Israel |
|Tel Aviv Souraski medical Center
|Tel Aviv, Israel |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 21, 2011
||December 9, 2014
||Israel: Ministry of Health
Keywords provided by Vibrant Ltd.:
ClinicalTrials.gov processed this record on March 26, 2015