CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,000 enrolled
Drug / intervention
Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00452426
NCT00452426Phase 3Completed
CompareCT.gov

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

Ethicon Endo-Surgery·interventional·Posted Mar 27, 2007·Updated Jan 25, 2011

In Brief

A Phase 3 clinical trial evaluating Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) and benzodiazepines and opioid sedation for Colonoscopy and 2 related conditions. Completed, enrolled 1,000 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy, Endoscopy, Digestive System, Conscious Sedation
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2007
Enrollment StartMar 1, 2007
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.3 years ago

Interventions

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

propofol sedation per device instructions for use

benzodiazepines and opioid sedationother

per site's current standard of care