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NCT02573818 Clinical Trial

Sedasys Post Approval Study Users Response to System Alarms

Conscious Sedation Clinical Trial

Official title:
Open-Label Post Approval Study of the SEDASYS System User Response to System Alarms

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02573818
Other study ID # SED-14-001
Secondary ID
Status Terminated
Phase N/A
First received October 6, 2015
Last updated March 22, 2017
Start date September 1, 2015
Est. completion date June 15, 2016

Study information
Verified date March 2017
Source Ethicon Endo-Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.

Recruitment information / eligibility
Status Terminated
Enrollment 51
Est. completion date June 15, 2016
Est. primary completion date June 15, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) I and II

- male and female

- Scheduled for routine colonoscopy or EGD

- =18 years of age

- Able to read, speak, and understand English

Exclusion Criteria:

- Physical or psychological condition which would impair trial participation, at the discretion of the PI

- BMI = 35

- Pregnancy or lactation

- Known or suspected hypersensitivity to propofol or fentanyl

- Use of a fentanyl patch

- Allergies to eggs, egg products soybeans or soy products

- Diagnosis of sleep apnea

- Gastroparesis

- Full stomach at the time of procedure

- Participation in any other investigational device or drug study within 30 days of enrollment

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SEDASYS System
propofol sedation with the SEDASYS System

Locations
Country Name City State
United States ProMedica Toledo Hospital Toledo Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary 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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