An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure
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|ClinicalTrials.gov Identifier: NCT02220192|
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|High-grade Cervical Intraepithelial Neoplasia||Procedure: Focal LEEP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||March 2016|
Experimental: Focal LEEP
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.
Procedure: Focal LEEP
Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.
- Number of cases of recurrent high-grade cervical intraepithelial neoplasia [ Time Frame: 6 months ]Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.
- Acceptability of focal LEEP procedure [ Time Frame: 2 weeks following focal LEEP procedure ]A 15-minute questionnaire will be conducted by phone with the patient.
- Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia [ Time Frame: Within 1 week following focal LEEP procedure ]A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220192
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Michelle J Khan, MD, MPH||University of Alabama of Birmingham|