Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical… (NCT07306260) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
China560 participantsStarted 2026-01
Plain-language summary
This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female, 25-60 years, understands study procedures and consents to participate;
. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
. Provides written informed consent.
Exclusion criteria
. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
. Undiagnosed vaginal bleeding;
. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
. Pregnant or breastfeeding women;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lesion effective rate
Timeframe: 6 months
Trial details
NCT IDNCT07306260
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University