SinusitisNCT02502084
Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
A study testing 3NT flexible endoscope in people with Sinusitis, run by 3NT Medical Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- 3NT flexible endoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Conditions
- Sinusitis
- Being tested
- 3NT flexible endoscope
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3NT flexible endoscopeDevice
Also called Sinusway
The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.
| Study group | Role | What they receive |
|---|---|---|
| 3NT flexible endoscope | Experimental | Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy Receives: Device: 3NT flexible endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by unanticipated device-related adverse events
Measured: During hospital stay, up to 1 day
Secondary outcomes (1)
Performance assessed by anatomical landmarks reached and visualized will be recorded
Measured: During procedure, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3NT Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502084
- Sponsor's protocol ID
- 3NT-IL1
- Status last verified
- Jan 2017
- First submitted
- 13 Jul 2015
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
- ClinicalTrials.gov ID
- NCT02502084
- Acronym / sponsor ID
- 3NT-IL1
- Conditions
- Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- 3NT Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3NT flexible endoscope | Experimental | Device: 3NT flexible endoscopeEvaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3NT flexible endoscopeAlso: SinuswayThe nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure. | Device | 3NT flexible endoscope |
Primary outcome
Safety assessed by unanticipated device-related adverse events
Time frame: During hospital stay, up to 1 day
1 secondary outcome
Performance assessed by anatomical landmarks reached and visualized will be recorded
Time frame: During procedure, up to 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3NT flexible endoscope in people with Sinusitis, run by 3NT Medical Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by unanticipated device-related adverse events (time frame: During hospital stay, up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.