Effect of Anesthesia on Force Application During Colonoscopy (CFM)

July 11, 2016 updated by: Artann Laboratories
The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.

Study Type

Observational

Enrollment (Actual)

102

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

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University Medical Center, Gastroenterology
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Endoscopy Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Univeristy of Pennsylvania Medical Center

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 participating sites 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
Intervention / Treatment
Patients undergoing colonoscopy
Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.
Device: Colonoscopy Force Monitor
Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.
Other Names:
  • CFM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak push force is increased in patients receiving propofol as compared to conscious sedation.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artann Laboratories

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Georgetown University
Capital Digestive Care, LLC

Investigators

  • Principal Investigator: Louis Y Korman, M.D., Capital Digestive Care, LLC

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

March 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

April 1, 2014

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFM-04
  • 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.

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