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Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD

NCT03390257 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-12-08

Study results available
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Summary

3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures

Conditions

  • Sinusitis

Interventions

DEVICE

3NT flexible endoscope

The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation

Sponsors & Collaborators

  • 3NT Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Jacob Johnson, MD · SF Otolaryngology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2018-03-21
Completion
2019-05-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390257 on ClinicalTrials.gov