Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Public ClinicalTrials.gov record NCT00452426. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00452426
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,000 participants
Conditions and interventions
Interventions
- Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System) Device
- benzodiazepines and opioid sedation Other
Device · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2007
- Primary completion
- Sep 30, 2007
- Completion
- Sep 30, 2007
- Last update posted
- Jan 24, 2011
2007
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Metropolitan Gastroenterology Group, PC | Washington D.C. | District of Columbia | 20006 | — |
| Fayetteville Gastroenterology Associates, PA | Fayetteville | North Carolina | 28304 | — |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | — |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | — |
| Digestive Health Specialists | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00452426, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 24, 2011 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00452426 live on ClinicalTrials.gov.