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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00797914

Enrollment

150

Registered

2008-11-25

Start date

2008-07-31

Completion date

2016-06-30

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Identify Characteristics of Colonoscopists During Endoscopy

Keywords

Colonoscopy, Instrumentation, Force Monitoring, Quality Control, Training

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
CFM can continuously record forces applied to colonoscope by different expert endoscopists during routine outpatient colonoscopy.	1 year

Secondary

Measure	Time frame
CFM can characterize differences in force patterns for different patients and different endoscopists	2 years

Countries

United States

Outcome results