A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;

• 18 to 60 years old;

• Agree to sign the informed consent;

Locations
Other Locations
China
Zhongnan Hospital of Wuhan University
RECRUITING
Wuhan
Contact Information
Primary
Yuanzhen Zhang, professor
wdzn2019@163.com
+86 13545364853
Backup
Kejia Wu, Doctor
wdzn2019@163.com
+86 13545364853
Time Frame
Start Date: 2022-07-07
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Radiofrequency group
AI Temperature-controlled Radiofrequency Technology
Active_comparator: Electrical stimulation group
Electrical Stimulation
Related Therapeutic Areas
Sponsors
Leads: Zhongnan Hospital

This content was sourced from clinicaltrials.gov