Collaborative Surgical Proficiency Initiative | NCT01050335

Studies
Collaborative Surgical Proficiency Initiative

NCT01050335

Sponsor

Phoenix Integrated Surgical Residency

Status

Unknown status

Last Update Posted

Jan 15, 2010Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Surgical Proficiency

Interventions

Simuvision Simulator

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

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 14, 2010

First Posted Date

Jan 15, 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

Jan 14, 2010

Last Update Posted Date

Jan 15, 2010Estimated

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 purpose of this study is to provide a quantitative base line comparison to determine a surgeon's proficiency based on that surgeon's hand and tool movements while performing simulation tasks.

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical resident or attending			Behavioral: Simuvision Simulator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simuvision Simulator	Behavioral	Participants will perform common surgical procedures on the simulator	Surgical resident or attending

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgical residents and attendings from Banner Good Samaritan Medical Center
Range in age from 23-65 years
Willing to provide informed consent

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Surgical residents and attendings from Banner Good Samaritan Medical Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kanav Kahol, PhD	Simulation and Education Training (SimET) Center, Banner Good Samaritan Medical Center	Principal Investigator
John Ferrara, MD	Phoenix Integrated Surgical Residency	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Simulation and Education Training (SimET) Center, Banner Good Samaritan Medical Center		Phoenix	Arizona	85006	United States