Focal Ablation of Cervical Precancer
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|ClinicalTrials.gov Identifier: NCT01709773|
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|High-grade Cervical Intraepithelial Neoplasia||Procedure: Focal treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Focal Ablation of High-grade Cervical Intraepithelial Neoplasia|
|Actual Study Start Date :||January 17, 2013|
|Actual Primary Completion Date :||April 11, 2014|
|Actual Study Completion Date :||May 26, 2014|
|Experimental: Focal treatment arm||
Procedure: Focal treatment
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
- Six-month recurrence rate of high-grade cervical intraepithelial neoplasia [ Time Frame: six months ]
- Safety of focal treatment [ Time Frame: six months ]Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).
- Acceptability of focal treatment [ Time Frame: six months ]Participants will be asked to respond to a survey at enrollment and follow-up asking whether they are satisfied with focal treatment as an alternative method of treatment.
- Feasibility of focal treatment [ Time Frame: enrollment ]Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
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): NCT01709773
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94109|
|Principal Investigator:||Karen Smith-McCune, MD, PhD||University of California, San Francisco|