NCT02847897

Evaluation of Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Vaginal Elasticity.

Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser for the Treatment of Vaginal Prolapse in Women.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following a screening visit, eligible subjects will be enrolled into the study. Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment. Further demographic information and patient history will be obtained from the subjects' electronical files.

Conditions

• Exposure Laser

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-07-01
• Completion: 2019-08-01
• First posted: 2016-07-28
• Last updated: 2019-08-08

Locations

1 site across 1 country: Israel