Sinusitis
Conditions
Keywords
Endoscopy, BSD
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 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.
Interventions
DEVICE3NT flexible endoscope
The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
Sponsors
3NT Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Device Effects | 4 hours | Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Sinuses Accessed and Visualized Successfully | 1 hour | Physician evaluation of the ability to access and visualize the paranasal sinuses. will be recorded as done/not done/failed |
| User Satisfaction (1-bad, 5-good) | 1 hour | Physician satisfaction questionnaire (1-bad, 5-good) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3nt Flexible Endoscope The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | 3nt Flexible Endoscope | — |
|---|---|---|
| Age, Continuous | 56.6 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 14 Participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Number of Adverse Device Effects
Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy
Time frame: 4 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3NT Flexible Endoscope | Number of Adverse Device Effects | 0 events |
Secondary
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
Time frame: 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3NT Flexible Endoscope | Percent of Sinuses Accessed and Visualized Successfully | Maxillary sinus | 60.5 percentage of sinuses |
| 3NT Flexible Endoscope | Percent of Sinuses Accessed and Visualized Successfully | Frontal sinus | 100 percentage of sinuses |
| 3NT Flexible Endoscope | Percent of Sinuses Accessed and Visualized Successfully | Sphenoid sinus | 68.5 percentage of sinuses |
Secondary
User Satisfaction (1-bad, 5-good)
Physician satisfaction questionnaire (1-bad, 5-good)
Time frame: 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3NT Flexible Endoscope | User Satisfaction (1-bad, 5-good) | Image quality | 4 score on a scale 1-5 | Standard Deviation 0.39 |
| 3NT Flexible Endoscope | User Satisfaction (1-bad, 5-good) | Ease of use | 4.4 score on a scale 1-5 | Standard Deviation 0.5 |
| 3NT Flexible Endoscope | User Satisfaction (1-bad, 5-good) | Lavage | 4.5 score on a scale 1-5 | Standard Deviation 0.52 |
| 3NT Flexible Endoscope | User Satisfaction (1-bad, 5-good) | Tolerability to patient | 4.6 score on a scale 1-5 | Standard Deviation 1.13 |
| 3NT Flexible Endoscope | User Satisfaction (1-bad, 5-good) | Maxillary sinus access | 4.8 score on a scale 1-5 | Standard Deviation 0.44 |
| 3NT Flexible Endoscope | User Satisfaction (1-bad, 5-good) | Frontal sinus access | 4.6 score on a scale 1-5 | Standard Deviation 0.52 |
| 3NT Flexible Endoscope | User Satisfaction (1-bad, 5-good) | Sphenoid sinus access | 4.7 score on a scale 1-5 | Standard Deviation 0.52 |