Sedasys Post Approval Study Users Response to System Alarms

• Sponsor: Ethicon Endo-Surgery (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02573818
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Actual Duration (Months): 9.5
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Device: SEDASYS System

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Open-Label Post Approval Study of the SEDASYS System User Response to System Alarms
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Jun 15, 2016
• Actual Study Completion Date: Jun 15, 2016

Arms and Interventions

Arm	Intervention/Treatment
SEDASYS System	Device: SEDASYS System; propofol sedation with the SEDASYS System

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ProMedica Toledo Hospital	Toledo	Ohio	United States	43617

Sponsors and Collaborators

• Ethicon Endo-Surgery

Investigators

• Study Director: James F Martin, PhD, Ethicon Endo-Surgery, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon Endo-Surgery
• ClinicalTrials.gov Identifier: NCT02573818
• Other Study ID Numbers: SED-14-001
• First Posted: Oct 12, 2015
• Last Update Posted: Mar 24, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ethicon Endo-Surgery: sedation for EGD and colonoscopy procedures

Study Results

No Results Posted as of Mar 24, 2017