Chart Review of Those Who Have Had Open, Laparoscopic, Ur... | NCT00395564

Studies
Chart Review of Those Who Have Had Open, Laparoscopic, Ureteroscopic, or Percutaneous Surgery

NCT00395564

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Dec 14, 2016Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Urologic Diseases

Interventions

Not provided

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

Dec 2016

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

Nov 2008

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Nov 1, 2006

First Submission Date that Met QC Criteria

Nov 1, 2006

First Posted Date

Nov 3, 2006Estimated

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

Dec 12, 2016

Last Update Posted Date

Dec 14, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Landman, Professor and Chairman, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Not provided

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 investigator intends to review retrospective de-identified data of patients who have had Open, Laparoscopic, Ureteroscopic or Percutaneous Urologic Surgery.

Detailed Description

The investigator reviews retrospective de-identified data of patients who have had Open, Laparoscopic, Ureteroscopic or Percutaneous Urologic Surgery in order to determine different clinical or operative issues.

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

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Develop outcome effectiveness for minimally invasive procedures		December 2015

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must have had Open, Laparoscopic, Ureteroscopic or Percutaneous Urologic Surgery at UCIMC Department of Urology

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

Those who have urologic conditions that need to be treated with open, laparoscopic, ureteroscopic, or percutaneous urologic surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elspeth McDougall	University of California Irvine-Department of Urology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine Medical Center		Orange	California	92868	United States

Condition Browse Module

MeSH Terms

ID	Term
D014570	Urologic Diseases

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided