Trials / Active Not Recruiting
Active Not RecruitingNCT06202274
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Candela Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
Detailed description
Subjects may receive treatment with one applicator or combination of any of the devices and applicators and/or additional commercial devices, products, and procedures. Evaluations may include combination treatments, sequential treatments, split face treatments, exploration of treatment and system parameters, and evaluation of exploratory indications. Treatments may include evaluation of commercial Candela systems with modification in hardware or software and/or treatment outside of treatment guidelines and exploratory indications (off-label) for evaluation of clinical feedback, device components, and treatment outcomes. Subjects may receive up to twelve (12) treatments. Treatments may occur with a minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. The number and interval of treatments will depend upon the device(s), treatment area, and indication to be treated. Follow-up visits may be required per PI discretion. Follow-up visits may occur virtually or in person.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Nordlys, Gentle, Picoway, Vbeam, Profound, Profound Matrix, eTwo, Exceed, CO2RE | Subjects will receive up to twelve (12) treatments at minimum treatment interval of 2 weeks and maximum treatment interval of 12 weeks. |
Timeline
- Start date
- 2023-10-04
- Primary completion
- 2028-10-04
- Completion
- 2029-10-04
- First posted
- 2024-01-11
- Last updated
- 2025-08-22
Locations
3 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06202274. Inclusion in this directory is not an endorsement.