Characterize Differences in Force Patterns Used by Differ... | NCT01029899

Studies
Characterize Differences in Force Patterns Used by Different Endoscopists and Trainee Endoscopists

NCT01029899

Sponsor

Artann Laboratories

Status

Completed

Last Update Posted

Jul 12, 2016Estimated

Enrollment

153Actual

Phase

Not provided

Conditions

Compare Performance of Colonoscopists

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

ID	Type	Description	Link
2R44DK068936	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 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

Dec 2009

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 9, 2009

First Posted Date

Dec 10, 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

Jul 11, 2016

Last Update Posted Date

Jul 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Artann LaboratoriesINDUSTRY

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
Georgetown University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 study is to evaluate how doctors in training are different from very experienced doctors when using force to perform colonoscopy with a device that monitors the amount of force applied to the colonoscope during colonoscopy.

Detailed Description

The study consists of two sequential observational studies designed to identify which instrument should be used to assess trainee performance and to quantify trainee skill development in performance of colonoscopy over the course of their training program.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

153Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colonoscopy Force Monitoring demonstrates patterns of how doctors in training are different from very experienced doctors when they do colonoscopy.		18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing diagnostic or screening colonoscopy ASA Class I or II
All ethnic and racial groups will be included
Able to comprehend, sign and date the written informed consent form (ICF)
English is their primary language

Exclusion Criteria:

Chronic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor
Specific pathology that would limit the extent of examination
ASA class 3 or greater
Pregnancy
Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

All adult male and female patients between the ages of 30 and 75 presenting for screening or diagnostic colonoscopy to be performed by any of the investigators.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armen Sarvazyan, Ph.D., D.Sc.	Artann Laboratories	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States
The University of Washington

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22840291	Result	Korman LY, Brandt LJ, Metz DC, Haddad NG, Benjamin SB, Lazerow SK, Miller HL, Greenwald DA, Desale S, Patel M, Sarvazyan A. Segmental increases in force application during colonoscope insertion: quantitative analysis using force monitoring technology. Gastrointest Endosc. 2012 Oct;76(4):867-72. doi: 10.1016/j.gie.2012.05.030. Epub 2012 Jul 27.