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

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ClinicalTrials.gov Identifier: NCT03390257
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
3NT Medical Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Sinusitis Device: 3NT flexible endoscope Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Sinusitis

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 Balloon Sinus Dilation
Other Name: Balloon sinus dilation




Primary Outcome Measures :
  1. Type, frequency and severity of Adverse device effects [ Time Frame: Day of procedure ]
    Adverse Device Effects (type, frequency, severity) are expected to be similar to those reported in literature for Nasal Endoscopy


Secondary Outcome Measures :
  1. Ability to access and visualize the paranasal sinuses [ Time Frame: Day of procedure ]
    Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed

  2. User satisfaction [ Time Frame: Day of procedure ]
    Physician satisfaction questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390257


Contacts
Contact: Ehud Bendory 972544657761 ehud@3ntmedical.com

Locations
United States, California
SF Otolaryngology Recruiting
San Francisco, California, United States, 94108
Contact: Jacob Johnson, MD       Jacob.Johnson@phonak.com   
United States, Utah
Ogden Clinic Recruiting
Salt Lake City, Utah, United States, 84403
Contact: Nadim Bikhazi, MD       Nadim.Bikhazi@ogdenclinic.com   
Sponsors and Collaborators
3NT Medical Ltd.
Investigators
Principal Investigator: Jacob Johnson, MD SF Otolaryngology

Responsible Party: 3NT Medical Ltd.
ClinicalTrials.gov Identifier: NCT03390257     History of Changes
Other Study ID Numbers: SD001
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by 3NT Medical Ltd.:
Endoscopy, BSD

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases