Fiber-Optic Confocal Microscopy of the Urinary Tract Hist... | NCT00801762

Studies
Fiber-Optic Confocal Microscopy of the Urinary Tract Histopathology

NCT00801762

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 22, 2019Actual

Enrollment

195Actual

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Fibered confocal microscope

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

Apr 2019

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

Sep 2008Actual

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Dec 2, 2008

First Submission Date that Met QC Criteria

Dec 2, 2008

First Posted Date

Dec 3, 2008Estimated

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

Apr 19, 2019

Last Update Posted Date

Apr 22, 2019Actual

Name	Class
Mauna Kea Technologies	INDUSTRY

Description Module

Brief Summary

The goal of the study is to develop a novel approach to obtain real time optical biopsy of urinary tract pathology (e.g., bladder tumors) during urinary tract endoscopy using a novel fibered confocal microscope.

Detailed Description

Not provided

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

195Actual

Name	Type	Description	Arm Group Labels	Other Names
Fibered confocal microscope	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Research subjects with suspected urinary tract pathology (e.g., bladder tumors) who are scheduled to undergo cystoscopy with possible excisional biopsy (e.g. transurethral resection of bladder tumor) in the operating room.
 Exclusion Criteria:History of hypersensitivity to fluorescein; active urinary tract infection; pregnant; currently breast feeding;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph C. Liao	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Palo Alto Health Care System		Palo Alto	California	94304	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19683270	Derived	Sonn GA, Jones SN, Tarin TV, Du CB, Mach KE, Jensen KC, Liao JC. Optical biopsy of human bladder neoplasia with in vivo confocal laser endomicroscopy. J Urol. 2009 Oct;182(4):1299-305. doi: 10.1016/j.juro.2009.06.039. Epub 2009 Aug 14.

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms