Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
NCT ID: NCT07290426
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2026-03-31
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Phase I: Safety
1. Screening and Enrollment Visit
2. Up to Three (3) Treatment Visits (with treatment intervals from 2 weeks to 6 weeks).
3. 7 Day (+/- 5 days) Follow Up Visit following Each Treatment Session (may be a virtual telephone or video visit)
4. Additional follow-up visits may be required per the discretion of the principal investigator to assess safety and healing progression
Phase II: Safety, Efficacy, and Optimization of Treatment Parameters
1. Screening and Enrollment Visit
2. Treatment visits are limited to up to eight (8) study treatments (with treatment intervals from 1 week to 8 weeks).
3. Follow-up #1 (4 weeks - 8 weeks)
4. Follow-up #2 (8 weeks - 16 weeks) (optional)
Additional follow up visits may be added, if necessary, per Sponsor and investigators' discretion.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vbeam Pro Treatment Group
Treatment with Vbeam Pro Laser System, up to eight (8) study treatments
Vbeam Pro Laser Treatment
Treatment with Vbeam Pro Laser System
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vbeam Pro Laser Treatment
Treatment with Vbeam Pro Laser System
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Presence of one or more vascular lesion, cutaneous lesion, or other dermatological condition deemed fit for treatment
3. Able and willing to comply with the treatment/follow-up schedule and comply with all study (protocol) requirements.
4. Willing to provide signed, informed consent to participate in the study
5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials
Exclusion Criteria
2. Known photosensitivity to 595nm or 1064 nm light
3. History of light-induced seizure disorders
4. Severe unstable concurrent conditions, such as unstable cardiac disorders
5. Use of implanted medical device including pacemakers, cardioverters and other implantable devices or fillers per investigator discretion (consultation with physicians prior to treatment is required)
6. Use of photosensitizing medications (medications that introduce photosensitivity or medications within or above the 595 nm wavelength, refer to Candela's list of drugs that may cause photosensitivity)
7. Tattoos (including decorative, permanent makeup and radiation port tattoos) in the intended study treatment area (595nm use only)
8. Active Herpes Simplex Virus (HSV) in the intended treatment area unless treated with prophylactic medication
9. The intended treatment area has significant sun exposure within the past 2 weeks or self-tanner has been applied to the treatment area
10. In the opinion of the Investigator, the subject is unwilling or unable to adhere to the study requirements or is otherwise unsuitable for the study
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Candela Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VBP25005
Identifier Type: -
Identifier Source: org_study_id