Spots Global Cancer Trial Database for How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?

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Trial Identification

Brief Title: How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?

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

Study ID: NCT02500966

Conditions

Stenosis Cervix

Interventions

DUDA device

LEEP

Study Description

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.