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Phase I Study for Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy


N/A
30 Years
75 Years
Open (Enrolling by invite only)
Both
Identify Characteristics of Colonoscopists During Endoscopy

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Trial Information

Phase I Study for Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy


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. Six expert endoscopists will use the CFM™ to perform
colonoscopy in 30 patients. The data will be recorded and analyzed for differences by
patient characteristics(e.g. gender, age, pain sensation, surgical history) and by
endoscopist.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Louis Y Korman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Capital Digestive Care, LLC

Authority:

United States: Institutional Review Board

Study ID:

CFM-01

NCT ID:

NCT00797914

Start Date:

July 2008

Completion Date:

June 2013

Related Keywords:

  • Identify Characteristics of Colonoscopists During Endoscopy
  • Colonoscopy
  • Instrumentation
  • Force Monitoring
  • Quality Control
  • Training

Name

Location

Chevy Chase Endoscopy CenterChevy Chase, Maryland  20815