Comparing AI Radiofrequency and Electrical Stimulation for Vulvar Leukoplakia Treatment
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
NA · Zhongnan Hospital · NCT05250466
This study is testing whether a new AI radiofrequency treatment works better than electrical stimulation for helping women with vulvar leukoplakia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Zhongnan Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05250466 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of AI temperature-controlled radiofrequency technology versus electrical stimulation in treating vulvar leukoplakia. It is a multicenter, randomized, open-label trial involving 120 patients, who are divided into two groups for treatment. The study aims to determine which intervention provides better outcomes for patients diagnosed with this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 60 who have been diagnosed with vulvar leukoplakia.
Not a fit: Patients with severe liver or kidney dysfunction, active infections, cardiovascular diseases, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from vulvar leukoplakia.
How similar studies have performed: While there is limited information on similar studies, the use of AI technology in medical treatments is an emerging field, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia; 2. 18 to 60 years old; 3. Agree to sign the informed consent; Exclusion Criteria: 1. Patients with severe liver and kidney dysfunction; 2. Combined with HIV, syphilis infection, acute vaginitis, cervical cancer; 3. Patients with cardiovascular disease; 4. People with hematological diseases; 5. Patients with hypertension and diabetes; 6. People with mental illness; 7. Pregnant and lactating women.
Where this trial is running
Wuhan, Hubei
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Yuanzhen Zhang, professor
- Email: wdzn2019@163.com
- Phone: +86 13545364853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vulvar Lichen Sclerosus