ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

December 20, 2017
January 4, 2018
January 4, 2018
April 25, 2017
April 2018   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
  • User satisfaction [ Time Frame: Day of procedure ]
    Physician satisfaction questionnaire
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation
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
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Sinusitis
Device: 3NT flexible endoscope
The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
Other Name: Balloon sinus dilation
Experimental: 3NT flexible endoscope
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
Intervention: Device: 3NT flexible endoscope
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Same as current
July 2018
April 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Ehud Bendory 972544657761 ehud@3ntmedical.com
United States
 
 
NCT03390257
SD001
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
Plan to Share IPD: No
3NT Medical Ltd.
3NT Medical Ltd.
Not Provided
Principal Investigator: Jacob Johnson, MD SF Otolaryngology
3NT Medical Ltd.
December 2017

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