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

NCT00797914 | Completed

• 2 other identifiers: CFM-015R44DK068936
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Identify Characteristics of Colonoscopists During Endoscopy

Keywords

Colonoscopy; Instrumentation; Force Monitoring; Quality Control; Training

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• CFM can characterize differences in force patterns for different patients and different endoscopists

  2 years

Study Arms (1)

Patients undergoing colonoscopy

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

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female
• Age: 30-75 years
• ASA Class I or II
• All ethnic and racial groups will be included

You may not qualify if:

• 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

Sponsors & Collaborators

• Artann Laboratories: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Capital Digestive Care, LLC: collaborator
• Mayo Clinic: collaborator
• Sansum Clinic: collaborator
• Georgetown University: collaborator

Study Sites (3)

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, 20815, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Korman LY, Egorov V, Tsuryupa S, Corbin B, Anderson M, Sarvazyan N, Sarvazyan A. Characterization of forces applied by endoscopists during colonoscopy by using a wireless colonoscopy force monitor. Gastrointest Endosc. 2010 Feb;71(2):327-34. doi: 10.1016/j.gie.2009.08.029. Epub 2009 Nov 17.

  PMID: 19922923 RESULT

Study Officials

• Louis Y Korman, M.D.

  Capital Digestive Care, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2008
• First Posted: November 25, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

US (3)