Robotic-Assisted Laparoscopic Cystectomy | NCT00969514

Studies
Robotic-Assisted Laparoscopic Cystectomy

NCT00969514

Sponsor

Corewell Health East

Status

Completed

Last Update Posted

Oct 3, 2011Estimated

Enrollment

31Estimated

Phase

Not provided

Conditions

Cystectomy

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

Sep 2011

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

Aug 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Aug 31, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

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

Sep 30, 2011

Last Update Posted Date

Oct 3, 2011Estimated

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

Robotic cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences.

Detailed Description

Robotic Cystectomy is a relatively new procedure previously described only at university centers. These studies have all been reviews of single surgeon's experiences. Our objective is to investigate our results from this novel procedure.

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

31Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic cystectomy		Patients undergoing robotic laparoscopic cystectomy at Beaumont Hospital-RO

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing robotic cystectomy at Beaumont Hospital

Exclusion Criteria:

None

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

Patients undergoing robotic cystectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Don BUI, MD	Beaumont Hospitals-RO	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beaumont Hospitals_RO		Royal Oak	Michigan	48073	United States