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

NCT ID: NCT02502084

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sinusitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3NT flexible endoscope

Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy

Group Type EXPERIMENTAL

3NT flexible endoscope

Intervention Type DEVICE

The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.

Interventions

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3NT flexible endoscope

The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.

Intervention Type DEVICE

Other Intervention Names

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Sinusway

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3NT Medical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ghent University

Ghent, , Belgium

Site Status

Assuta Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Belgium Israel

Other Identifiers

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3NT-IL1

Identifier Type: -

Identifier Source: org_study_id