SinusitisNCT03390257
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
A study testing 3NT flexible endoscope in people with Sinusitis, run by 3NT Medical Ltd. at 2 sites in United States.
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 years and older
- 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
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Apr 2017to 2 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist
- Patient age: adult (>18 years old)
- Patients in general good health in the opinion of the investigator as determined by medical history and 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
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ogden Clinic
Salt Lake City, Utah, 84403
SF Otolaryngology
San Francisco, California, 94108
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Sinusitis
- Being tested
- 3NT flexible endoscope
- Keywords
- Endoscopy, BSD
- 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 Balloon sinus dilation
The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
| 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.
Number of Adverse Device Effects
Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy
Measured: 4 hours
Secondary outcomes (2)
Percent of Sinuses Accessed and Visualized Successfully
Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed
Measured: 1 hour
User Satisfaction (1-bad, 5-good)
Physician satisfaction questionnaire
(1-bad, 5-good)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start25 Apr 2017
- Primary completion21 Mar 2018
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3NT Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Johnson, MD, Principal investigator, SF Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390257
- Sponsor's protocol ID
- SD001
- Status last verified
- Oct 2020
- First submitted
- 20 Dec 2017
- Last updated
- 8 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. 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 in Conjunction With Sinus Balloon Dilation
- ClinicalTrials.gov ID
- NCT03390257
- Acronym / sponsor ID
- SD001
- Conditions
- Sinusitis
- Keywords
- Endoscopy, BSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- 3NT Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Posted 8 Dec 2020
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 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.
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist
- Patient age: adult (>18 years old)
- Patients in general good health in the opinion of the investigator as determined by medical history and 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 (2 listed)
- 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)
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: Balloon sinus dilationThe nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation | Device | 3NT flexible endoscope |
Primary outcome
Number of Adverse Device Effects
Time frame: 4 hours
Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy
2 secondary outcomes
Percent of Sinuses Accessed and Visualized Successfully
Time frame: 1 hour
User Satisfaction (1-bad, 5-good)
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sinusitis
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Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
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Endotypic Stability in CRS
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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.
Jacob Johnson, MD principal investigator
SF Otolaryngology
2 sites in 1 country: 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 United States.
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 2 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 8 Dec 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Device Effects (time frame: 4 hours). 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 8 Dec 2020; AzTrials last refreshed its copy on 1 Nov 2026.