NCT00452426View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions
ColonoscopyEndoscopy, Digestive SystemConscious 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

Trial Locations (7)

20006

Metropolitan Gastroenterology Group, PC, Washington D.C.

22911

Charlottesville Medical Research, Charlottesville

27103

Digestive Health Specialists, PA, Winston-Salem

28304

Fayetteville Gastroenterology Associates, PA, Fayetteville

37205

Nashville Medical Research Institute, Nashville

44195

The Cleveland Clinic Foundation, Cleveland

98405

Digestive Health Specialists, Tacoma

All Listed Sponsors
lead

Ethicon Endo-Surgery

INDUSTRY

NCT00452426 - Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy | Biotech Hunter | Biotech Hunter