University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
NCT Number: NCT02220192
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.
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Notify Me21 year–45 year
Female
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 2 weeks following focal LEEP procedure
A 15-minute questionnaire will be conducted by phone with the patient.
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.
University of Alabama at Birmingham
Other
Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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