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:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT06120205
Eligibility Criteria:
Group 1: Inclusion Criteria - General Population Group
1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
Group 2: Inclusion Criteria - Enriched Population Group
1. Participant is 25 to 65 years of age and willing to provide informed consent.
2. Participant has an intact cervix.
3. One or more of the below:
* Prior diagnosis of hrHPV within previous 6 months and/or
* Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or
* Presenting for colposcopy/LEEP/excisional intervention
Exclusion Criteria - All Groups
1. Participant has impaired decision-making capacity or is unable to provide informed consent.
2. Participant has undergone partial or complete hysterectomy including removal of the cervix.
3. Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior \< 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.
4. Participant is pregnant (based on self-reporting).
5. Participant who reports or is experiencing menstrual bleeding.
6. Participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.
7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT06120205
Study Brief:
Protocol Section:
NCT06120205