Safety Evaluation of the Vibrating Capsule (Vibrant)
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:||April 2014|
|Estimated 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.
|Contact: Ron Yishai, Dr.||email@example.com|
|Barzilai MC||Not yet recruiting|
|Contact: Shmuel Delgado, MD 972-54-6340366 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Ron Yishai|