Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01723956
Eligibility Criteria:
Inclusion Criteria:
* Women 18-65 years of age
* Not menstruating (if menstruating, the patient can be screened at another date)
* Able to sign consent
* Able to follow the study protocol
* HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1)
* Participant with histology-proven CIN 2 or 3 disease
Exclusion Criteria:
* Pregnant
* Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management)
* Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy)
* Previous hysterectomy with removal of the cervix
* Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk
* Cervical dysplastic lesions that are not appropriate for cryotherapy, defined as the following:
1. Lesion is greater than ≥75% cervix
2. Lesion entering into the cervical canal and the complete lesion cannot be visualized
3. Presence of abnormal vasculature
4. Lesion bigger that the cryotherapy probe
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01723956
Study Brief:
Protocol Section:
NCT01723956