Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses

December 20, 2017 updated by: 3NT Medical Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The rationale behind this feasibility study is to show that accessing and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in patients suffering from symptoms attributable to sinusitis is feasible; This is an essential step in the development of a system that will later allow visualization, sampling, and treatment of the sinuses via the natural sinus ostium during the patient's first office visit in a minimally invasive manner while enabling treatment by lavage, and minimizing radiation exposure, antibiotic use, multiple office visits, and cost.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University
  • Israel
      • Tel Aviv, Israel
        • Assuta Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient indicated for primary FESS procedure by the ear, nose and throat (ENT) specialist
  • Patient age: adult (>18 years old)
  • Patients in general good health in the opinion of the investigator as determined by medical history physical examination
  • A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent

Exclusion Criteria:

  • A patient with nasal polyposis
  • A patient indicated for tumor excision
  • Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
  • Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)
  • Pregnancy
  • Patients with previous FESS surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3NT flexible endoscope
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
Device: 3NT flexible endoscope
The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.
Other Names:
  • Sinusway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety assessed by unanticipated device-related adverse events
Time Frame: During hospital stay, up to 1 day
During hospital stay, up to 1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Performance assessed by anatomical landmarks reached and visualized will be recorded
Time Frame: During procedure, up to 3 hours
During procedure, up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

3NT Medical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3NT-IL1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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