Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy

This study has been completed.

First Received: March 26, 2007 Last Updated: September 30, 2009 History of Changes

Sponsor:	Ethicon Endo-Surgery
Information provided by:	Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT00452426

Purpose

Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.

Condition	Intervention	Phase
Colonoscopy Endoscopy, Digestive System Conscious Sedation	Device: Computer-Assisted Personalized Sedation (CAPS) Device	Phase III

Study Type:	Interventional
Study Design:	Screening, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-center Pivotal Clinical Trial to Compare the Safety and Effectiveness of Procedural Sedation in GI Endoscopy: A Computer-Assisted Personalized Sedation (CAPS) Device Versus Current Standard of Care

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy Endoscopy

Drug Information available for: Propofol

U.S. FDA Resources

Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:

Area under the curve (AUC) for oxygen desaturation

Secondary Outcome Measures:

Duration of deep sedation/general anesthesia
Patient satisfaction
Clinician satisfaction
Recovery time (from sedation)

Enrollment:	1000
Study Start Date:	March 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

≥ 18 years old
Able to comprehend, sign, and date the written informed consent form
English as primary language
Undergoing a non-emergent EGD or colonoscopy
Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure
American Society of Anesthesiologists (ASA) Class I, II or III

Exclusion Criteria:

Allergy or inability to tolerate study medications or components of study medications
Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty
Currently using a fentanyl patch
History of diagnosed sleep apnea
History of diagnosed gastroparesis
Baseline oxygen saturation < 90% (room air)
Pregnant or nursing females
Body mass index (BMI) ≥ 35
Participation in a clinical trial within the past 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452426

Locations

United States, District of Columbia
Metropolitan Gastroenterology Group, PC
Washington, District of Columbia, United States, 20006
Metropolitan Gastroenterology Group, PC
Washington, District of Columbia, United States, 20006
United States, North Carolina
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
Fayetteville Gastroenterology Associates, PA
Fayetteville, North Carolina, United States, 28304
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
United States, Washington
Digestive Health Specialists
Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Ethicon Endo-Surgery

Investigators

Study Director:

James Martin, PhD

Ethicon Endo-Surgery, Inc.

More Information

No publications provided

Responsible Party:	EES ( James Martin )
Study ID Numbers:	CI-06-0004
Study First Received:	March 26, 2007
Last Updated:	September 30, 2009
ClinicalTrials.gov Identifier:	NCT00452426 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ethicon Endo-Surgery:

Propofol
Diprivan
Colonoscopy
Endoscopy, Digestive System
Conscious Sedation

ClinicalTrials.gov processed this record on February 09, 2010