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The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vibrating capsule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrant capsule | Device | vibrating capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements | 7.5 weeks of treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spontaneous bowel movement per week compared to baseline | 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 | 9.5 weeks |
| Patient assessment of capsule tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Souraski medical Center | Tel Aviv | Israel | Israel | |||
| Barzilai MC |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 7.5 weeks of treatment period |
| Ashkelon |
| Israel |
| Italian Hospital | Nazeret | Israel |