NCT07290426

Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions

A Prospective Clinical Study Evaluating Pulse Dye Laser on Clearance of Vascular Indications

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Candela Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study to evaluate the safety and performance of the Vbeam Pro Laser System for the treatment of vascular indications, including rosacea and port wine stain birthmarks.

Detailed description

Study Design This is a non-randomized, open-label clinical study evaluating clinical treatments with the Vbeam Pro system for the treatment of vascular indications, including rosacea and port wine stain birthmarks. There are two phases of this study: 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

• Rosacea
• Vascular Diseases
• Port-Wine Stain

Interventions

Type	Name	Description
DEVICE	Vbeam Pro Laser Treatment	Treatment with Vbeam Pro Laser System

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Regulatory

• FDA-regulated device study