Vibrant capsule
Devicevibrating capsule
Other names: Vibrant
NCT Number: NCT01306448
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Tel Aviv Souraski medical Center, Tel Aviv, Israel
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
vibrating capsule
Other names: Vibrant
Time frame: 7.5 weeks of treatment period
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
Time frame: 9.5 weeks
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
Time frame: 7.5 weeks of treatment period
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.
Vibrant Ltd.
Industry
Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
Acronym: Vibrant
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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