Effect of Anesthesia on Force Application During Colonoscopy

NCT02101099 | Completed DMC

• 2 other identifiers: CFM-045R44DK068936
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Colonoscopy; Force; Monitor; Endoscopist; Conscious; Sedation; Propofol

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (1)

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

Colonoscopy Force Monitor DEVICE

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

Also known as: CFM

Patients undergoing colonoscopy

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 participating sites 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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Capital Digestive Care, LLC: collaborator
• University of Pennsylvania: collaborator
• Georgetown University: collaborator

Study Sites (3)

Georgetown University Medical Center, Gastroenterology

Washington D.C., District of Columbia, 20057, United States

Location

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, 20815, United States

Location

Univeristy of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

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: March 28, 2014
• First Posted: April 1, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

US (3)