Sedasys Post Approval Study Users Response to System Alarms

Stopped early

Conditions studied: Conscious Sedation

In brief

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

Key facts

Study ID

NCT02573818

Run by

Ethicon Endo-Surgery

People needed

51

Starts

2015-09-01

Expected to finish

2016-06-15

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ProMedica Toledo Hospital — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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