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

NCT00452426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2011-01-25

Study results available
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Summary

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.

Conditions

  • Colonoscopy
  • Endoscopy, Digestive System
  • Conscious Sedation

Interventions

DEVICE

Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System)

propofol sedation per device instructions for use

OTHER

benzodiazepines and opioid sedation

per site's current standard of care

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • James Martin, PhD · Ethicon Endo-Surgery, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452426 on ClinicalTrials.gov