Clinical Trial: An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach

Brief Summary: 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.

Detailed Summary: Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Alabama at Birmingham

Dates:
Date Received: August 7, 2014
Date Started: December 2014
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016