NCT00855829

A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea

A Single-Center, Randomized, Controlled, Double-Blind Feasibility Study Designed to Assess the Safety Performance of ActiLady Prototype in Adult Female Subjects With Dysmenorrhea.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DEVICE	Miniature Actilady device active	Devices: Targeted pressure waves are created by two kind of methods ActiLady). 1. 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. 2. Self manufactured device inserted into the vaginal cavity and creating subsound pressure waves.
DEVICE	Miniature Actilady device not active	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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-05-01
• Completion: 2013-10-01
• First posted: 2009-03-04
• Last updated: 2013-11-13

Locations

2 sites across 1 country: Israel