Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound (NCT02890277) | Clinical Trial Compass
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Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound
China120 participantsStarted 2016-01
Plain-language summary
Nonneoplastic epithelial disorders of skin and mucosa of vulva refer to a group of chronic diseases shown as female genital skin and mucosal tissue degeneration and pigmentation change. The main symptoms are vulval itching, squamous cell hyperplasia, vulval and perianal skin atrophy or thinning, hypopigmentation. The current treatments are primarily local drug or surgical treatments. However, the effect is not good enough, but the diseases often recur and severely affect patients' quality of life. In this study, the investigators combined the technology of high intensity focused ultrasound (HIFU) (ultrasound device made by Mianyang Sonic electronic LLC, Mianyang China, registration number: 2005-2230099} with special drug to treat. The data from colposcopy and biopsy pathology were collected before and after treatment to create the objective identifying degree of the disease by with "grading methods" and evaluate the treatment effect. At the meantime, the standardized treatment procedure, methods and efficacy criterion were all stipulated to achieve satisfactory results, which could be used to clinical treatments. So far, the investigators have not seen similar study reported internationally.
Who can participate
Age range
18 Years – 78 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* patients with clinically and biopsy confirmed non-neoplastic lesions of genital skin and mucous membrane (non-neoplasia epithelial disorders of skin and mucosa of vulva).
Symptoms include repeated itching, discoloration, rhagades, loss of skin elasticity and dyspareunia that affect the patients' quality of life.
Exclusion criteria:
* atypical hyperplasia or vulvar cancer confirmed by biopsy of genital lesions;
* vulvovaginal or other gynecological trauma, acute inflammatory diseases and other acute illness in need of urgent care;
* combined with other serious gynecological diseases (symptomatic hysteromyoma, ovarian tumor, etc.), and/or severe organ diseases (such as heart, lung, brain and renal disease/failure) that need immediate treatment;
* other type of cancers that require urgent care.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Grading changes of nonneoplastic epithelial disorders from colposcopy and biopsy pathology
Timeframe: One month before treatment and 2,4,6 weeks and 2,6,12,24 monthes after treatment