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COMPLETEDPhase 1/2NCT01895062

Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy

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...

Lead sponsor: 5i Sciences, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

5i Sciences, Inc.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 6, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1/PHASE2

Enrollment54

Start dateMar 2013

Last updatedAug 6, 2014

Condition

Airway Obstruction Apnea Hypopnea

Locations shown

Scripps Green Clinic

La Jolla, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2014Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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