Status:
COMPLETED
TRICIN: Prospective Study on the Efficacy of Single Topical Trichloroacetic Acid (TCA) 85% in the Treatment of Cervical Intraepithelial Neoplasia (CIN 1/2)
Lead Sponsor:
Krankenhaus Barmherzige Schwestern Linz
Collaborating Sponsors:
Medical University of Vienna
Conditions:
Cervical Intraepithelial Neoplasia Grade 1
Cervical Intraepithelial Neoplasia Grade 2
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
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...
Detailed Description
Visit and assessment Schedule: Visit1 Screening: * Informed Consent, * Inclusion/Exclusion Criteria, * Medical History, * Gynecological Examination * Cytology * HPV Test * Colposcopy * Biopsy * VAS ...
Eligibility Criteria
Inclusion
- Histologically proven CIN 1/2
- adequate colposcopy (i.e. fully visible transformation zone and margins of any visible lesion)
- positive HPV test
- conducted negative pregnancy test
- women aged 18 to 50 years
- written informed consent
Exclusion
- Exclusion criteria are a cytologically suspected CIN (Pap IIID, IV)
- inadequate colposcopy
- negative or missing biopsy
- cytology results indicating invasive disease (PAP V)
- if the cervical lesion recedes into the endocervical canal
- pregnancy
- any medical circumstance considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
Key Trial Info
Start Date :
February 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04400578
Start Date
February 7 2020
End Date
January 18 2022
Last Update
April 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of gynaecology, Ordensklinikum Linz Ges.m.b.H, Barmherzige Schwestern
Linz, Austria, 4010