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

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ClinicalTrials.gov Identifier: NCT02502084
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : December 22, 2017
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 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  (Clinical Trial)
Actual Enrollment : 17 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
Study Start Date : August 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

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 functional endoscopic sinus surgery (FESS) procedure.
Other Name: Sinusway




Primary Outcome Measures :
  1. Safety assessed by unanticipated device-related adverse events [ Time Frame: During hospital stay, up to 1 day ]

Secondary Outcome Measures :
  1. Performance assessed by anatomical landmarks reached and visualized will be recorded [ Time Frame: During procedure, up to 3 hours ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02502084


Locations
Belgium
Ghent University
Ghent, Belgium, 9000
Israel
Assuta Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
3NT Medical Ltd.

Responsible Party: 3NT Medical Ltd.
ClinicalTrials.gov Identifier: NCT02502084     History of Changes
Other Study ID Numbers: 3NT-IL1
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: January 2017

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