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A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair

NCT04492176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-05-03

No results posted yet for this study

Summary

1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. Laser therapy with small trauma and short repair time has attracted much attention.
2. CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection.
3. It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells.

Conditions

  • Vaginal Atrophy

Interventions

DEVICE

CO2 fractional laser（ACUPULSE,Lumenis）

gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Gang Wang · Dermatology Derpartment of Xijing Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-09-30
Completion
2020-10-30
FDA Device
Yes

Countries

  • China

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 NCT04492176 on ClinicalTrials.gov