Vascular LesionPhase 1NCT00585338
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
A Phase 1 study testing Tandem 532/1064 nm Laser in people with Vascular Lesion, run by University of California, Irvine at 1 site in United States.
Trial summary
Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation. It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Lesion
- What is being tested?
- Tandem 532/1064 nm Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age 18 years and older
- Diagnosis of vascular lesion
Who cannot join
- Age <18
- Pregnancy
- History of cutaneous photosensitivity
- Any therapy to the proposed treatment sites within the previous two months
- Current participation in any other investigational drug or device evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical and Surgical Clinic
Irvine, California, 92612
About this study
Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation.
It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal.
The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.
Read the detailed description
The researcher can determine the blanching of vascular lesions after Tandem laser with multiple 532/1064 nm laser pulses treatment.
The researcher will select one to four test sites spots for laser treatment. will be Different laser parameters can be used for each test site. The research will evaluate of the test sites at 6-12 weeks for bruising and blanching. Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.
- Conditions
- Vascular Lesion
- Being tested
- Tandem 532/1064 nm Laser
- Keywords
- facial telangiectasia,, leg vein telangiectasia, Port Wine Stain birthmarks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem 532/1064 nm LaserDevice
Also called Treatment of Vascular Lesions
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
| Study group | Role | What they receive |
|---|---|---|
| Tandem 532/1064 nm Laser | Experimental | Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser Receives: Device: Tandem 532/1064 nm Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser treatment
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular LesionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- John S Nelson, M.D, PhD, Study director, Beckman Laser Institute University of California IrvineWangcun Jia, PhD, Principal investigator, Beckman Laser Institute University of California IrvineKristen Kelly, M.D, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585338
- Sponsor's protocol ID
- 20033086
- Status last verified
- Oct 2022
- First submitted
- 18 Dec 2007
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
- ClinicalTrials.gov ID
- NCT00585338
- Acronym / sponsor ID
- 20033086
- Conditions
- Vascular Lesion
- Keywords
- facial telangiectasia,, leg vein telangiectasia, Port Wine Stain birthmarks
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Dec 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation.
It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal.
The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.
Detailed description
The researcher can determine the blanching of vascular lesions after Tandem laser with multiple 532/1064 nm laser pulses treatment.
The researcher will select one to four test sites spots for laser treatment. will be Different laser parameters can be used for each test site. The research will evaluate of the test sites at 6-12 weeks for bruising and blanching. Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tandem 532/1064 nm Laser | Experimental | Device: Tandem 532/1064 nm LaserTreatment of Vascular LesionsWith a Tandem 532/1064 nm Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult age 18 years and older
- Diagnosis of vascular lesion
Key exclusion criteria (5 listed)
- Age <18
- Pregnancy
- History of cutaneous photosensitivity
- Any therapy to the proposed treatment sites within the previous two months
- Current participation in any other investigational drug or device evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tandem 532/1064 nm LaserAlso: Treatment of Vascular LesionsTreatment of Vascular Lesions With a Tandem 532/1064 nm Laser | Device | Tandem 532/1064 nm Laser |
Primary outcome
Laser treatment
Time frame: 6 months
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Nelson, M.D, PhD study director
Beckman Laser Institute University of California Irvine
Wangcun Jia, PhD principal investigator
Beckman Laser Institute University of California Irvine
Kristen Kelly, M.D principal investigator
Beckman Laser Institute University of California Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tandem 532/1064 nm Laser in people with Vascular Lesion, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.