Evaluation of Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Vaginal Elasticity.
NCT02847897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2019-08-08
Summary
The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with vaginal prolapse. Eligible subjects will receive 3 treatment sessions, 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
Conditions
- Exposure Laser
Interventions
- DEVICE
-
CO2 AcuPulse Laser
Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
Sponsors & Collaborators
-
Rambam Health Care Campus
lead OTHER
Principal Investigators
-
Lior Lowenstein, MD · Rambam Health Care Campus
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-01
- Primary Completion
- 2019-07-01
- Completion
- 2019-08-01
Countries
- Israel
Study Locations
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