Safety Evaluation of the Vibrating Capsule (Vibrant)
Recruitment status was Recruiting
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals|
- 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
- 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:||March 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||September 2012 (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.
|Contact: Ron Yishai, Dr.||firstname.lastname@example.org|
|Barzilai MC||Not yet recruiting|
|Contact: Shmuel Delgado, MD 972-54-6340366 email@example.com|
|Principal Investigator: Shmuel Delgado, MD|
|Italian Hospital||Not yet recruiting|
|Contact: Rifaat Safadi SAFADI@hadassah.org.il|
|Principal Investigator: Rifaat Safadi, MD|
|Tel Aviv Souraski medical Center||Recruiting|
|Tel Aviv, Israel|
|Contact: Ron Yishai, MD 972-52-4266852 firstname.lastname@example.org|
|Principal Investigator: Ron Yishai|