Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05668806
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2022-11-18
Brief Title:
RWE Study in the Treatment of Cervical Lesions of Various Etiology
Sponsor:
Perfect Care Distribution
Organization:
Perfect Care Distribution
Study Overview
Official Title:
Study of Real-world Evidence in Patients Treated With Cerviron Vaginal Ovules in the Treatment of Cervical Lesions of Various Etiology
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
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:
The aim of the study was to assess the post-market performance and tolerability of Cerviron ovules in the treatment and management of cervical lesions of different etiologies The study included clinical data related to aspect of lesions performed during routine colposcopy exams the degree of re-epithelialization of the cervical mucosa vaginal pH pain level and vaginal bleeding level
Detailed Description:
This study is an observational post-marketing study conducted between May-July 2021
The aim of the study was to assess the post-market performance and tolerability of Cerviron ovules in the treatment and management of cervical lesions of different etiologies
The secondary objective of this clinical investigation is the assessment of performance of the medical device by clinical exam and patients degree of satisfaction related to the use of the medical device
The study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion
The aim of the study was to assess the post-market performance and tolerability of Cerviron ovules in the treatment and management of cervical lesions of different etiologies
The secondary objective of this clinical investigation is the assessment of performance of the medical device by clinical exam and patients degree of satisfaction related to the use of the medical device
The study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion
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