Evaluation of Handheld Colonoscopy Force Monitor by Expert Endoscopists in the Performance of Colonoscopy

Artann Laboratories

Status: Completed

Conditions: Identify Characteristics of Colonoscopists During Endoscopy

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT00797914

5R44DK068936 (U.S. NIH Grant/Contract)

CFM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Patients undergoing colonoscopy

Description:

Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.