Back to resultsSafety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
Primary Purpose
Sinusitis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
3NT flexible endoscope
Sponsored by
About this trial
This is an interventional diagnostic trial for Sinusitis
Eligibility 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
Sites / Locations
- Ghent University
- Assuta Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3NT flexible endoscope
Arm Description
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
Outcomes
Primary Outcome Measures
Safety assessed by unanticipated device-related adverse events
Secondary Outcome Measures
Performance assessed by anatomical landmarks reached and visualized will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02502084
Brief Title
Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
Official Title
Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3NT Medical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3NT flexible endoscope
Arm Type
Experimental
Arm Description
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
Intervention Type
Device
Intervention Name(s)
3NT flexible endoscope
Other Intervention Name(s)
Sinusway
Intervention Description
The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.
Primary Outcome Measure Information:
Title
Safety assessed by unanticipated device-related adverse events
Time Frame
During hospital stay, up to 1 day
Secondary Outcome Measure Information:
Title
Performance assessed by anatomical landmarks reached and visualized will be recorded
Time Frame
During procedure, up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Assuta Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
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