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NCT01362192 · ClinicalTrials.gov registry record · Phase 4
Treatment of Lower Extremity Spider Veins With Excel V
A Phase 4 study, sponsored by Cutera.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01362192: Completed Phase 4 study, sponsored by Cutera.
NCT01362192 is a Phase 4 study that has completed, run by Cutera. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362192, a Phase 4 study, has completed, sponsored by Cutera.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser. The Excel V laser has received 510(k) clearance from the FDA, which means the FDA has approved the laser for dermatological and vascular conditions, like spider veins.
Primary Outcome
A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale: * 0 = No Improvement (0%) * 1 = Mild Improvement (\< 25%) * 2 = Moderate Improvement (26 to 50%) * 3 = Signi
Interventions
- DEVICE 532 nm KTP Excel V Laser, manufactured by Cutera, Inc.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-11 |
| Phase | Phase 4 |
What the finished NCT01362192 record still lists
NCT01362192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which 532 nm KTP Excel V Laser, manufactured by Cutera, Inc. is the first listed.
NCT01362192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01362192 about?
NCT01362192 is a clinical study titled "Treatment of Lower Extremity Spider Veins With Excel V". The purpose of this study is to evaluate the safety and effectiveness of a new laser for the removal of unsightly spider veins on the legs. The device used in this study is the Cutera Excel V laser, which is a dual wavelength 532 nm potassium titanyl phosphate (KTP) and 1064 nm neodymium-doped yttri...
What is the current status of trial NCT01362192?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2011-05. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01362192?
The interventions under investigation include: 532 nm KTP Excel V Laser, manufactured by Cutera, Inc. (DEVICE).
Who is sponsoring clinical trial NCT01362192?
This trial is sponsored by Cutera, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01362192's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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