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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
3NT Medical Ltd.
ClinicalTrials.gov Identifier:
NCT02502084
First received: July 13, 2015
Last updated: February 6, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Sinusitis
Device: 3NT flexible endoscope
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses

Resource links provided by NLM:


Further study details as provided by 3NT Medical Ltd.:

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

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

Enrollment: 17
Study Start Date: August 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02502084

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

Responsible Party: 3NT Medical Ltd.
ClinicalTrials.gov Identifier: NCT02502084     History of Changes
Other Study ID Numbers: 3NT-IL1
Study First Received: July 13, 2015
Last Updated: February 6, 2017

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

ClinicalTrials.gov processed this record on May 25, 2017