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ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Miniature Actilady device active | Active Comparator | one miniature Actilady device tested for all patients during a 4 months period. The device is active in 3 months out of the 4, and the patients are blinded to the action of the device (sham comparator). |
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| Miniature Actilady device not active | Sham Comparator | Sham Comparator: one miniature Actilady device tested for all patients during a 4 months period. The device is active in 3 months out of the 4, and the patients are blinded to the action of the device (sham comparator). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miniature Actilady device active | Device | Devices: Targeted pressure waves are created by two kind of methods ActiLady).
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of a novel method and device called ActiLady. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| * Evaluate the pain-reducing effect of ActiLady on dysmenorrhea. * Study the relationship between menses flux and dysmenorrhea. [Time Frame: 6 months] [Designated as safety issue: No ] * Optimize treatment procedure and wave form. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | 91120 | Israel | |||
| Hadassah Medical Organization |
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| Miniature Actilady device not active | Device | Devices: Targeted pressure waves are created by two kind of methods ActiLady). The effect of the waves used will be examined by the use of a silicon tube or polyvinyl chloride (PVC) tube which is inserted into the vaginal cavity. The other end of the tube will be connected to an "off the shelf" pressure waves generator and controller. Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves. |
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| Jerusalem |
| 91120 |
| Israel |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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