Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02890277
Status:
UNKNOWN
Last Update Posted:
2017-01-13
First Post:
2015-02-14
Brief Title:
Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound
Sponsor:
Jinan Military General Hospital
Organization:
Jinan Military General Hospital
Study Overview
Official Title:
Treatment of Nonneoplastic Epithelial Disorders of Skin and Mucosa of Vulva With High Intensity Focused Ultrasound
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None