Trials / Completed
CompletedNCT02500966
How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 265 (actual)
- Sponsor
- Barretos Cancer Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DUDA device | Insertion DUDA device |
| PROCEDURE | LEEP | Loop Electrosurgical Excision Procedure |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2018-06-01
- Completion
- 2019-01-07
- First posted
- 2015-07-17
- Last updated
- 2020-01-18
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02500966. Inclusion in this directory is not an endorsement.