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The Effect of Additional Laser Treatments.

NCT04111952 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2022-04-20

No results posted yet for this study

Summary

Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.

Conditions

  • Lax Vaginal Introitus

Interventions

DEVICE

CO2 laser

A single session of CO2 vaginal laser treatment

DEVICE

Sham laser

A single session of sham laser treatment.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Roy Lauterbach, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-11-01
Completion
2023-01-28

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04111952 on ClinicalTrials.gov