Trials / Unknown
UnknownNCT04484415
Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
A Double Blind, Prospective, Randomized, Placebo Controlled, Multi-center Phase 3 Study to Evaluate Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 402 (actual)
- Sponsor
- Asieris MediTech (Hong Kong) Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL).
Detailed description
To evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients with cervical histologic HSIL.A total of 384 subjects will be enrolled globally, among which, 300 subjects of them will be enrolled in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Cevira® | The device is a single-use, disposable, LED-based red light source. The device will automatically switch on the light 5 hours after administration, and provide continuous photoactivation of 125 J/cm2 over 4.6 hours before automatically shutting down. |
| COMBINATION_PRODUCT | Placebo | The placebo device is identical in appearance as the Cevira® device, but does not provide light. |
Timeline
- Start date
- 2020-11-10
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2020-07-23
- Last updated
- 2022-08-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04484415. Inclusion in this directory is not an endorsement.