Status:
COMPLETED
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
Lead Sponsor:
5i Sciences, Inc.
Conditions:
Airway Obstruction
Apnea
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cNEP) to the upper airway as a means of preventing episodes of respirat...
Eligibility Criteria
Inclusion
- Male or female subjects undergoing elective colonoscopy at the Study Site who have fewer than three or more than three positive responses on the STOP BANG questionnaire
Exclusion
- Presence of severe cardiopulmonary or neurologic disease as determined by the investigator
- History of vascular fragility associated with cutaneous pressure
- History of hypersensitivity to silicone
- Inability to properly fit cNEP collar to the subject
- The presence of excessive facial hair in the region where the cNEP collar is positioned
- Known carotid vascular disease, previous major neck surgery or radiation therapy to the cervical region
- Presence of anatomical abnormalities in the neck or pharyngeal region (such as enlarged tonsils)
- Inability to provide informed consent
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01895062
Start Date
March 1 2013
End Date
March 1 2014
Last Update
August 6 2014
Active Locations (1)
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1
Scripps Green Clinic
La Jolla, California, United States, 92037