Sedasys Post Approval Study Users Response to System Alarms

Ethicon

Status: Terminated

Conditions: Conscious Sedation

Treatments: Device: SEDASYS System

Study type: Observational

Funder types: Industry

Identifiers

NCT02573818

SED-14-001

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

51 participants in 1 patient group

SEDASYS System

Treatment:

Device: SEDASYS System