NCT00452426

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Ethicon Endo-Surgery · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-03-27
• Last updated: 2011-01-25
• Results posted: 2011-01-25

Locations

7 sites across 1 country: United States