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franchise closed; no safety concerns
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The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEDASYS System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEDASYS System | Device | propofol sedation with the SEDASYS System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms) | <24 hours, i.e., for duration of study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC) | assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects 18 years or older scheduled for colonoscopy or EGD
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| Name | Affiliation | Role |
|---|---|---|
| James F Martin, PhD | Ethicon Endo-Surgery, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProMedica Toledo Hospital | Toledo | Ohio | 43617 | United States |
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