Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452426
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2007-03-26
Brief Title:
Safety and Effectiveness of a Computer-Assisted Personalized Sedation CAPS Device for Propofol Delivery During Endoscopy
Sponsor:
Ethicon Endo-Surgery
Organization:
Ethicon Endo-Surgery
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 physicianregistered nurse RN team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None