Clinical trial · Interventional
Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2
NCT07306260CI-TRIAL-00099760PDT for CIN2not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIN 2 | Cervical Squamous Intraepithelial Neoplasia 2 | ALIAS | 0.90 |
| HPV (Human Papillomavirus)-Associated | — | UNRESOLVED | — |
| HSIL, High Grade Squamous Intraepithelial Lesion | High Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| Photodynamic Therapy (PDT) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALA-PDT | Procedure | — | UNRESOLVED |
| LEEP surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ALA-PDT Group
- description
- ALA-PDT treatment for cervical lesions 6 to 9 times
- interventionNames
- Procedure: ALA-PDT
- type
- ACTIVE_COMPARATOR
- label
- LEEP Group
- description
- LEEP surgery for cervical lesions
- interventionNames
- Procedure: LEEP surgery
Primary outcomes (1)
- measure
- Lesion effective rate
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, 25-60 years, understands study procedures and consents to participate; 2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2; 3. Provides written informed consent. Exclusion Criteria: 1. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer; 2. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall; 3. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically; 4. Undiagnosed vaginal bleeding; 5. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents; 6. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies; 7. Pregnant or breastfeeding women; 8. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser); 9. Use of interferon or antiviral therapy within 3 months; 10. Any other condition deemed unsuitable for participation by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.