An interventional study of Trichloroacetic acid 85% (TCA) in Cervical Intraepithelial Neoplasia Grade 1 and Cervical Intraepithelial Neoplasia Grade 2, sponsored by Krankenhaus Barmherzige Schwestern Linz. Completed at 1 site in Austria. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Krankenhaus Barmherzige Schwestern Linz · Not applicable, Interventional, and Treatment
Trichloroacetic acid 85% =TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2. The device system is to be used only in accordance with the approved Investigational Plan on subjects, who have given written informed consent.
High remission and regression rates are expected after a single topical treatment with 85% TCA. After a single topical treatment with 85% TCA for CIN 1-2 (Expected 70% or higher; null hypothesis: not higher than 55%). Regression is defined as improvement from high grade lesion (CIN 2) at baseline to low grade lesion (CIN 1) after TCA treatment. Regression from CIN 1 normal squamous epithelium after the TCA treatment is equal to remission and will be counted as a remission in combined analysis. Remission is defined as complete histologic remission of CIN back to normal squamous epithelium after the TCA treatment, i.e., no cervical dysplasia is detectable by histology or cytology after the TCA treatment. Type-specific HPV Clearance is defined as disappearance of the HPV type detected at screening.
Visit and assessment Schedule:
Visit1 Screening:
Visit 2 Treatment Day with TCA 85%:
Visit 3, Control 1, Week 10-14:
Visit 4, Control 2, Week 22-26:
Visit 5, EOS , Week 24-30:
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 102 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Krankenhaus Barmherzige Schwestern Linz is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
If a patient is eligible 1. local anesthesia with Xylocain 10% with a pump spray for a period of 10 seconds- one time application 2. Procain 2%: local anesthesia with a swab for a period of 10 seconds- one time application 3. Trichloroacetic acid TCA 85% 1-2 ml with soaked swab for max. 2 minutes -one time application
Device: Trichloroacetic acid 85% (TCA)
Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.
CIN remission rate after treatment with TCA 85%
measured by histologic remission within 6 months
Time frame: 6 months
CIN regression rate after treatment with TCA 85%
measured by histologic regression within 6 (improvement of at least one clinical CIN grade) months
Time frame: 6 months
Pain scores
measured by Visual Analogue Scale of a single use of TCA 85% in patients with CIN 1/2
Time frame: 6 months
Type specific human papillomavirus clearance rate after treatment with TCA 85%
human papillomavirus clearance rate after treatment with TCA 85% with CIN I/CIN // within 6 months
Time frame: 6 months
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Krankenhaus Barmherzige Schwestern Linz