Clinical trial · Interventional
An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure
Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach
NCT02220192CI-TRIAL-00021655completedN/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)
This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.
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 |
|---|---|---|---|
| High-grade Cervical Intraepithelial Neoplasia | High Grade Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal LEEP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focal LEEP
- description
- All patients will undergo focal treatment of high-grade cervical intraepithelial neoplasia using LEEP. A two-week follow-up assessment will evaluate the side effects of the treatment and any unusual symptoms. This will be done through a phone survey. At six months a clinic visit is required to assess whether there are any precancerous cells of the patient's cervix.
- interventionNames
- Procedure: Focal LEEP
Primary outcomes (1)
- measure
- Number of cases of recurrent high-grade cervical intraepithelial neoplasia
- timeFrame
- 6 months
- description
- Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21-45 years old * Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or CIN2/3). A copy of the pathology report is required at the time of enrollment. We will only include patients that had their biopsy performed at the UAB Colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic. * Focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix. * Satisfactory (adequate) colposcopy. * Lives within 100 miles of the University of Alabama at Birmingham. Exclusion Criteria: * Any suspicion for invasive cancer. * Glandular abnormalities on cytology or histology. * Cervical lesion incompletely visualized (e.g. extending into the endocervical canal). * Endocervical curettage positive for high-grade cervical intraepithelial neoplasia. * Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient that lives \>100 miles away will be excluded due to concern for possible loss to follow-up. * Immunosuppression (HIV positive, history of transplantation, lupus on immunosuppressive medication, etc.). * Pregnancy. * Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.