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

NCT ID: NCT03390257

Last Updated: 2020-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2019-05-02

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 access and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in conjunction with Balloon Sinus Dilation in patients suffering from symptoms attributable to sinusitis is feasible in the office and operating room settings; This is an essential step in the development of a combined dilation and visualization system that will allow visualization, dilation and lavage of the sinuses via their natural ostia during an office visit, and minimize radiation exposure, antibiotic use, multiple office visits, and cost.

Conditions

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Sinusitis

Keywords

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Endoscopy, BSD

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 Balloon Sinus Dilation

Interventions

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3NT flexible endoscope

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

Intervention Type DEVICE

Other Intervention Names

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Balloon sinus dilation

Eligibility Criteria

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Inclusion Criteria

1. Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist
2. Patient age: adult (\>18 years old)
3. Patients in general good health in the opinion of the investigator as determined by medical history and physical examination
4. 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

1. Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
2. Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)
Minimum Eligible Age

18 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

Principal Investigators

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Jacob Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

SF Otolaryngology

Locations

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SF Otolaryngology

San Francisco, California, United States

Site Status

Ogden Clinic

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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SD001

Identifier Type: -

Identifier Source: org_study_id