Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT02500966
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2015-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?
Sponsor:
Barretos Cancer Hospital
Organization:
Study Overview
Official Title:
A Randomized Study to Evaluate the Safety, Efficacy and Quality of Life of a New Device to Prevent Cervical Stenosis After LEEP in High Grade Cervical Dysplasia
Status:
COMPLETED
Status Verified Date:
2018-06
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:
DUDA
Brief Summary:
Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and amenorrhea. This study will test a new device named DUDA Device ("Dispositivo Uterino para dilatar canal endocervical") placed just after the conization, in order to evaluate the safety, efficacy and quality of life.
Detailed Description:
This device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (SCJ) of the cervix during follow-up of this patient.
Study Oversight
Has Oversight DMC:
True
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?: