Clinical trial
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS)…
NCT00452426 · Ethicon Endo-Surgery, Industry · Completed
Key facts
| NCT number | NCT00452426 |
|---|---|
| Title | Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy |
| 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 |
| Lead sponsor | Ethicon Endo-Surgery, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Colonoscopy, Endoscopy, Digestive System, Conscious Sedation |
| Intervention type | Device, Other |
| Interventions | Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System), benzodiazepines and opioid sedation |
| Enrollment | 1,000 |
| Start date | Mar 1, 2007 |
| Primary completion | Oct 1, 2007 |
| Completion | Oct 1, 2007 |
| First posted | Mar 27, 2007 |
| Last update posted | Jan 25, 2011 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: