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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00452426

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.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 7:00 AM EDT

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

Study identification

NCT ID
NCT00452426
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ethicon Endo-Surgery
Industry
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 Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00452426 live on ClinicalTrials.gov.

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