Monitoring the Response of Port Wine Stain Birthmarks to... | NCT01333553

Studies
Monitoring the Response of Port Wine Stain Birthmarks to Laser Therapy With Wide-field Functional Imaging Technologies

NCT01333553

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

69Actual

Phase

Not provided

Conditions

PORT WINE STAIN

Interventions

Image-guided remove Port Wine Stain

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Aug 3, 2010

First Submission Date that Met QC Criteria

Apr 8, 2011

First Posted Date

Apr 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Bernard Choi, Ph.D., Assistant Professor Biomedical Engineering, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The researcher develop non-invasive imaging modalities for assessment of port wine stain during laser therapy treatment of Port Wine Stain. The imaging modalities will be used to guide immediate retreatment of regions of persistent perfusion during the procedure.

Detailed Description

The researcher can use imaging system operates by projecting low-power near-infrared structured light patterns on to the tissue of interest in a non-contact, reflection geometry and then capturing the reflectance with a camera.The system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive visualization of sub-surface structures of Port Wine Stain.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Image-guided remove Port Wine Stain		Image-guided surgery remove Port Wine Stain	Device: Image-guided remove Port Wine Stain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Image-guided remove Port Wine Stain	Device	Image-guided surgery remove Port Wine Stain	Image-guided remove Port Wine Stain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Image-guided surgery remove Port Wine Stain	Image-guided surgery remove Port Wine Stain	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All minors, birth to 18 years of age or older with Port Wine Stain birthmark
Ability to understand and carry out subject instructions
Sign photograph release form

Exclusion Criteria:

Inability to understand and/or carry out instructions
Pregnant women
Do not sign photograph release form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Study population will be selected from an outpatient population with Port Wine Stain birthmark at Beckman Laser Institute and Medical Clinic, University of California, Irvine. Patients with Port Wine Stain birthmark will be candidates for participation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Choi, PhD	Beckman Laser Institute University of California Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute Medical clinic		Irvine	California	92612	United States

Condition Browse Module

MeSH Terms

ID	Term
D019339	Port-Wine Stain

Ancestor Terms

ID	Term
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided