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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3NT flexible endoscope | Experimental | Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3NT flexible endoscope | Device | The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Device Effects | Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 hour |
| User Satisfaction (1-bad, 5-good) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Johnson, MD | SF Otolaryngology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SF Otolaryngology | San Francisco | California | 94108 | United States | ||
| Ogden Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3NT Flexible Endoscope | Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy 3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3nt Flexible Endoscope | The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | events | 4 hours |
|
|
day of procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3NT Flexible Endoscope | Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy 3NT flexible endoscope: The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation No Adverse events were reported during this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacob Johnson | SF Otolaryngology | 4153625443 | jjohnson@sfotomed.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2017 | Oct 28, 2020 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2017 | Oct 28, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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Physician satisfaction questionnaire
(1-bad, 5-good)
| 1 hour |
| Salt Lake City |
| Utah |
| 84403 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 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 | Posted | Number | percentage of sinuses | 1 hour |
|
|
|
| Secondary | User Satisfaction (1-bad, 5-good) | Physician satisfaction questionnaire (1-bad, 5-good) | Posted | Mean | Standard Deviation | score on a scale 1-5 | 1 hour |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Measurements |
|---|
|
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| Tolerability to patient |
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| Maxillary sinus access |
|
| Frontal sinus access |
|
| Sphenoid sinus access |
|