Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy
July 11, 2016 updated by: Artann Laboratories
Phase I Study for Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy
The purpose of this study is to evaluate a handheld Colonoscopy Force Monitor(CFM™), a push-pull force and torque measuring device, that grips the shaft of the colonoscope and wirelessly transmits and records all the forces applied by the endoscopist during colonoscopy.
Study Overview
Status
Completed
Detailed Description
Colonoscopy requires a skilled endoscopist to use visual and tactile information to advance and withdraw the instrument through a series of fixed and stationary loops.
To develop and maintain the skills necessary to perform colonoscopy safely and effectively requires extensive training and ongoing education.
Quantification of tactile information provides the opportunity to understand the "feel" used by the endoscopist to perform colonoscopy.
The identification of force application patterns has the potential to enhance training and improve performance.
CFM™ is a handheld device that uses load cells to transform applied force to electric signals and to transmit wirelessly the signal to a computer for storage and visual display.
The device is designed so that the endoscopist maintains a conventional hand position and uses an electronically controlled grip and release mechanism to fix the position on the instrument.
Several expert endoscopists from multiple institutions will use the CFM™ to perform colonoscopy.
The data will be recorded and analyzed for differences by patient characteristics(e.g.
gender, age, pain sensation, surgical history) and by endoscopist.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Barbara, California, United States, 93105
- Sansum Clinic
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Maryland
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Chevy Chase, Maryland, United States, 20815
- Chevy Chase Endoscopy Center
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All adult male and female patients between the ages of 30 and 75 presenting to the Chevy Chase Endoscopy Center for screening or diagnostic colonoscopy to be performed by any of the investigators will be considered for inclusion.
Description
Inclusion Criteria:
- Male or female
- Age: 30-75 years
- ASA Class I or II
- All ethnic and racial groups will be included
Exclusion Criteria:
- Colonic 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
- Monitored anesthesia using propofol for sedation.
- Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients undergoing colonoscopy
Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy.
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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CFM can characterize differences in force patterns for different patients and different endoscopists
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Louis Y Korman, M.D., Capital Digestive Care, LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 23, 2008
First Submitted That Met QC Criteria
November 24, 2008
First Posted (Estimate)
November 25, 2008
Study Record Updates
Last Update Posted (Estimate)
July 12, 2016
Last Update Submitted That Met QC Criteria
July 11, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CFM-01
- 5R44DK068936 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.