Optical Coherence Tomography of Airway and Pleural Disorders | NCT00580892

Studies
Optical Coherence Tomography of Airway and Pleural Disorders

NCT00580892

Sponsor

University of California, Irvine

Status

Withdrawn

Last Update Posted

Oct 20, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Disorder of Pleura and Pleural Cavity

Interventions

Optical Coherence Tomography imaging

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not a clinical trial study

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Dec 27, 2007Estimated

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 19, 2022

Last Update Posted Date

Oct 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Matthew Brenner, M.D.,Department of Pulmonary and Critical Care Medicine, 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 can use Optical coherence tomography a near-infrared diode to emit light that can produce images of the specimen under investigation and provide information about tissue abnormalities without causing damage.

Detailed Description

The researcher can use Optical coherence tomography endoscopic imaging to improve diagnosis and treatment of airway and pleural malignancy. In the events of burn injury and smoke inhalation injury, the Optical coherence tomography can determine the change of the airway tissues and severity of airway injury.

During endoscopic procedure the lesions will be biopsied and prepared by standard histologic methods. The Optical coherence tomography endoscopic imaging can measured histologic of the tissue samples and compared to standard histologic examination. The Optical coherence tomography endoscopic imaging can measured the epithelial thickness and compared to visual inspection of the mucosa on bronchoscopy.

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
Airway and Pleural Disorders		Optical Coherence Tomography imaging	Device: Optical Coherence Tomography imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography imaging	Device	Optical Coherence Tomography imaging	Airway and Pleural Disorders

Measure	Description	Time Frame
histopathology		up to 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult 18 or older, male or female.
Plans for bronchoscopic with possible biopsy procedures.

Exclusion Criteria:

Age less than 18 years of age
Not plan for bronchoscopic with possible biopsy procedures.
Pregnant or breastfeeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study population will be selcted from University of California Irvine Chao Cancer Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Brenner, M.D	Beckman Laser Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary and Critical Care Medicine		Irvine	California	92612	United States