A Pilot Study Using Laser Speckle Imaging of Neonate Cere... | NCT01166880

Studies
A Pilot Study Using Laser Speckle Imaging of Neonate Cerebral Vasculature

NCT01166880

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Nov 1, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Newborn Distress

Interventions

Laser Speckle Imaging

Countries

Not provided

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to find grant fundingsupport to continue builds the study device.

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jul 20, 2010

First Submission Date that Met QC Criteria

Jul 20, 2010

First Posted Date

Jul 21, 2010Estimated

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
Children's Hospital of Orange County	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 want to know whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This approach is called laser speckle imaging

Detailed Description

This study involves imaging of superficial blood vessels in the infant's head. Analysis of reflected light images provides the type of data necessary to see the blood vessels.

The researcher want to assess only feasibility of our instrument. If we determine that our instrument has sufficient spatial resolution to image directly large vessels, then we will proceed with plans for a larger study with statistical power.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laser Speckle Imaging		Laser Speckle Imaging Infant Head Blood flow	Device: Laser Speckle Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser Speckle Imaging	Device	Laser Speckle Imaging Infant Head Blood flow	Laser Speckle Imaging

Measure	Description	Time Frame
Neonate Cerebral Blood Flow		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newborn

Exclusion Criteria:

non-new bron

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Month

Standard Ages

Child

Study Population

new born

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

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000081982	Laser Speckle Contrast Imaging

Ancestor Terms

ID	Term
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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