Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399341
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2024-05-01
Brief Title:
Clinical Effectiveness of PAPILOCARE in Regression of Cervix HPV Cytological Abnormalities PAPILOBS GR
Sponsor:
Elpen Pharmaceutical Co Inc
Organization:
Elpen Pharmaceutical Co Inc
Study Overview
Official Title:
PAPILOBS GR A Clinical Investigation to Assess the Effectiveness of PAPILOCARE in the Regression of Cervix Cytological Abnormalities Caused by HPV
Status:
COMPLETED
Status Verified Date:
2024-05
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:
PAPILOBSGR
Brief Summary:
The present study is a multicenter open non-interventional prospective observational clinical study for the evaluation of the effectiveness of Papilocare medical device with CE mark in the regression of cervix cytological abnormalities caused by HPV
Detailed Description:
524 participants were enrolled in the study from approximately 44 Greek sites At baseline Visit 1 written informed consent was obtained participants eligibility criteria were checked and medical history data were collected Participants were advised to be treated with Papilocare for 6 months 1 cannuladay for 21 days during first month 1 cannulaalternate days for subsequent 5 months At 6 months Visit 2 primary and secondary objectives were evaluated If needed and based on physicians decision treatment was extended to a total of 12 months Visit 3 and primary and secondary endpoints were evaluated as well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None