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CompletedNCT02101099CFMUpdated Jul 12, 2016

Effect of Anesthesia on Force Application During Colonoscopy

An observational study in Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases, sponsored by Artann Laboratories. Completed at 3 sites in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-12.

Sponsored by Artann Laboratories · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
102
Ages
30 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases

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Keywords

  • Colonoscopy
  • Force
  • Monitor
  • Endoscopist
  • Conscious
  • Sedation
  • Propofol
03

In context

Colonic Diseases

142 studies on the registry are indexed under Colonic Diseases; 22 are open to participants now.

This study's enrollment of 102 is below the median of 170 across 48 observational studies indexed under Colonic Diseases.

Browse Colonic Diseases studies →

Lead sponsor

Artann Laboratories is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
102 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients undergoing colonoscopy

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

    Device: Colonoscopy Force Monitor

Interventions

  • DeviceColonoscopy Force Monitor

    Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.

    Also known as: CFM

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What researchers measure

Primary outcomes

  1. Peak push force is increased in patients receiving propofol as compared to conscious sedation.

    Time frame: 6 months

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Study locations

3 sites
  • Georgetown University Medical Center, Gastroenterology
    Washington, District of Columbia 20057, United States
  • Chevy Chase Endoscopy Center
    Chevy Chase, Maryland 20815, United States
  • Univeristy of Pennsylvania Medical Center
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02101099
Lead sponsor
Artann Laboratories
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Capital Digestive Care, LLC, University of Pennsylvania, Georgetown University
Responsible party
Sponsor
First posted
Apr 1, 2014
Start date
Mar 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jul 12, 2016

Study contacts

Louis Y Korman, M.D.
principal investigator · Capital Digestive Care, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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