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Trial record 6 of 3592 for:    colon cancer AND Colonic Diseases

Effect of Anesthesia on Force Application During Colonoscopy (CFM)

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ClinicalTrials.gov Identifier: NCT02101099
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Capital Digestive Care, LLC
University of Pennsylvania
Georgetown University
Information provided by (Responsible Party):
Artann Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment
Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases Device: Colonoscopy Force Monitor

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.

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Anesthesia on Force Application During Colonoscopy
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: CFM




Primary Outcome Measures :
  1. Peak push force is increased in patients receiving propofol as compared to conscious sedation. [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101099


Locations
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United States, District of Columbia
Georgetown University Medical Center, Gastroenterology
Washington, District of Columbia, United States, 20057
United States, Maryland
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States, 20815
United States, Pennsylvania
Univeristy of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Artann Laboratories
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Capital Digestive Care, LLC
University of Pennsylvania
Georgetown University
Investigators
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Principal Investigator: Louis Y Korman, M.D. Capital Digestive Care, LLC

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Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT02101099     History of Changes
Other Study ID Numbers: CFM-04
5R44DK068936 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by Artann Laboratories:
Colonoscopy
Force
Monitor
Endoscopist
Conscious
Sedation
Propofol
Additional relevant MeSH terms:
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Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs