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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE July 13, 2015
First Posted Date  ICMJE July 20, 2015
Last Update Posted Date December 22, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
Safety assessed by unanticipated device-related adverse events [ Time Frame: During hospital stay, up to 1 day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2015)
Performance assessed by anatomical landmarks reached and visualized will be recorded [ Time Frame: During procedure, up to 3 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
Official Title  ICMJE Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sinusitis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 3NT flexible endoscope
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
Intervention: Device: 3NT flexible endoscope
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2017)
17
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2015)
10
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02502084
Other Study ID Numbers  ICMJE 3NT-IL1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 3NT Medical Ltd.
Study Sponsor  ICMJE 3NT Medical Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account 3NT Medical Ltd.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP