|
|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P080009 / PAS002 |
| Date Original Protocol Accepted |
03/29/2013
|
| Date Current Protocol Accepted |
03/25/2015
|
| Study Name |
Open Label Post Market Registry in Clinical Practi
|
| Device Name |
SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is an observational, single arm, non-randomized, non-blinded, multi-center, prospective, safety study of sedation with the SEDASYS System during colonoscopy and EGD, performed in routine clinical practice.
|
| Study Population |
Adult patients who satisfy the approved FDA labeling and are scheduled for non-emergent endoscopy procedures, including those from PAS I (CI-13-000X)
|
| Sample Size |
7430 patients; including subject population (approximately 866) from CI-13-000X (PAS I). This sample size will allow confidence of 99% that the rate is less than 1/1,000 (allowing for one anesthesia professional rescue intervention). No dropouts are anticipated.
There will be 40 - 60 trained users at up to 30 sites
Cases per Trained User 120-320
Cases per Institution 240-720
Anesthesia Professional Rescue Interventions per Trained User: <=1
Anesthesia Professional Rescue Interventions per Institution: <=1
|
| Key Study Endpoints |
Primary: Total number of anesthesia professional rescue interventions <=1
Secondary: Subjects sedated requiring BMV and/or AAI Safety:
The incidence of adverse events (AEs) will be assessed at the preferred term (PT) level using the Medical Dictionary for Regulatory Activities (MedDRA) for event categorization. Incidence of AEs will also be assessed by 1) onset time with respect to alarm condition; 2) relationship to endoscopic procedure (Colonoscopy or EGD); 3) relationship to the device (alarm response); and 4) severity.
|
| Follow-up Visits and Length of Follow-up |
Adult male and female subjects who satisfy the approved FDA labeling and are scheduled for non-emergent endoscopy procedures during the study timeframe will be invited to participate in the study. Patients will be enrolled with informed consent including those from companion study (CI-13-000X).
Visit 1: Screening.
Visit 2: Pre-procedure <=15 days of the procedure(Visit 1 (screening) and Visit 2 (procedure) could occur on the same day).
Length of Follow-up
1-day per patient.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
n/a
|
| Actual Number of Sites Enrolled |
n/a
|
| Patient Follow-up Rate |
n/a
|
| Final Safety Findings |
n/a
|
| Final Effect Findings |
n/a
|
| Study Strengths & Weaknesses |
n/a
|
| Recommendations for Labeling Changes |
no
|
