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

NCT02500966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

  • Stenosis Cervix

Interventions

DEVICE

DUDA device

Insertion DUDA device

PROCEDURE

LEEP

Loop Electrosurgical Excision Procedure

Sponsors & Collaborators

  • Barretos Cancer Hospital

    lead OTHER

Principal Investigators

  • Ricardo Reis, PHD · Director of the Teaching and Research Institute - Barretos Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-06-30
Completion
2019-01-07

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500966 on ClinicalTrials.gov