Clinical trial · Interventional
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
NCT02500966CI-TRIAL-00042841DUDAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stenosis Cervix | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DUDA device | Device | — | UNRESOLVED |
| LEEP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DUDA device
- description
- The number of patients to be recruited in this arm will be 145. Note: The first twenty-five patients who will be included in the study will be allocated in the intervention arm to safety analysis (phase 1); after that all eligible candidates will be randomized 1:1 (phase 2). Procedure: Loop Electrosurgical Excision Procedure (LEEP) followed by implantation of the device called DUDA (plastic device developed in barretos cancer hospital that will be placed after conization. It has 2.5 cm in length and 5mm in diameter and remains within the endocervical canal for 30 days and is set at 4 points with nonabsorbable sutures in the ectocervix.)
- interventionNames
- Device: DUDA device
- Procedure: LEEP
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- The number of patients to be recruited in this arm will be 120. Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device
- interventionNames
- Procedure: LEEP
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * High Grade Cervical Dysplasia, Grades 2 and 3, in the biopsy cervical * Patient eligible for conization * Patient must consent for the appropriate surgery * Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1 * Patients must have signed an approved informed consent and authorization permitting release of personal health information Exclusion Criteria: * Pregnancy * Previous conization * limited comprehension of the study * the risk of the American Society of Anesthesiologists, III or IV * HIV or immunodepression * Patients with a history of the invasive malignancies
References
Publications (0)
Data not yet available
No reference posted for this study.