Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibrating capsule | Active Comparator | patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. |
|
| sham non-vibrating capsule | Sham Comparator | patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vibrating capsule | Device | patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of bowel movements | change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups | 3 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
11. Participation in another clinical study in the last 4 months prior to screening.
12. Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.
13. Women who are pregnant or lactating.
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States | ||
| Georgia Regents University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sham non-vibrating capsule | Device | patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)]. |
|
| Augusta |
| Georgia |
| 30912 |
| United States |
| MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Mgh Boston | Boston | Massachusetts | 02114 | United States |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Albuquerque Neuroscience | Albuquerque | New Mexico | 87109 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | United States |
| CTRS LLC | Pittsburgh | Pennsylvania | 15206 | United States |
| Huoston Methodist Hosptial | Houston | Texas | 77030 | United States |
| Bat-Yamon | Bat Yam | Israel |
| Degani center Clalit MC | Hadera | Israel |
| Expert clinic Clalit MC | Herzliya | Israel |
| Talpiot clinic Clalit MC | Jerusalem | Israel |
| Zvoulon MC Clalit MC | Kiryat Bialik | Israel |
| 100 Tower | Tel Aviv | Israel |
| Souraski Medical Center | Tel Aviv | Israel |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided