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A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting.
This study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).
The objective for Group B in the study is to evaluate tolerability and safety of tympanostomy tube (TT) placement in adults following local anesthesia in a physician's clinic setting.
Group B will consist of 30 evaluable adults who require unilateral or bilateral tube insertion.
The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).
Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement. The subject will rate the pain upon TDS tube insertion using the VAS, and the pain score will be compared to a performance goal.
Safety will be evaluated post procedure and at a follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tube insertion using Tube Delivery System (TDS) | Other | Active Tymbion iontophoresis and tube insertion using the TDS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tymbion Iontophoresis and Tube Delivery System (TDS) | Combination Product | Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. | The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain". Following TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis. | Day of procedure (Day 0)- Immediately after tube placement |
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Inclusion Criteria:
Exclusion Criteria by Ear:
Significantly atrophic, retracted or retraction pocket at location of tube placement, bimeric, monomeric or atelectatic tympanic membrane.
Perforated tympanic membrane.
Otitis externa.
Hemotympanum.
Damaged/denuded skin in the auditory canal.
Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal.
Notable ear discomfort experienced during audiologic or otoscopic examination.
Anatomy that precludes sufficient visualization of and access to the tympanic membrane.
Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane.
General Exclusion Criteria
Pregnant or lactating females
History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics.
Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.
Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions
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| Name | Affiliation | Role |
|---|---|---|
| David Yen, MD | Specialty Physician Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento ENT | Roseville | California | 95661 | United States | ||
| Camino ENT |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tube Insertion Using Tube Delivery System (TDS) | Active Tymbion iontophoresis and tubes using the TDS Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2017 | Dec 16, 2019 |
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| San Jose |
| California |
| 95138 |
| United States |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | United States |
| Charlotte Eye Ear Nose and Throat Associates | Charlotte | North Carolina | 28105 | United States |
| Specialty Physician Associates | Bethlehem | Pennsylvania | 18017 | United States |
| South Carolina ENT | Lugoff | South Carolina | 29078 | United States |
| Carolina Ear, Nose and Throat | Orangeburg | South Carolina | 29118 | United States |
| Ear Medical Group | San Antonio | Texas | 78240 | United States |
| COMPLETED | Participants undergoing iontophoresis with adequate anesthesia for tube placement. |
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| NOT COMPLETED |
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Participants for whom iontophoresis is initiated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tube Insertion Using Tube Delivery System (TDS) | Active Tymbion iontophoresis and tubes using the TDS Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. | The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain". Following TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis. | Posted | Mean | Standard Deviation | millimeters | Day of procedure (Day 0)- Immediately after tube placement |
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Procedure through 3-week post-procedure follow-up visit.
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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 | Tube Insertion Using Tube Delivery System (TDS) | Active Tymbion iontophoresis and tubes using the TDS Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement. | 0 | 30 | 0 | 30 | 10 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inadequate anesthesia | Ear and labyrinth disorders | Systematic Assessment | Potentially related to procedure, device or drug |
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| Ear discomfort | Ear and labyrinth disorders | Systematic Assessment | Potentially related to procedure, device or drug |
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| Tube in middle ear | Ear and labyrinth disorders | Systematic Assessment | Potentially related to procedure, device or drug |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment | Potentially related to procedure, device or drug |
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| Dizziness | Ear and labyrinth disorders | Systematic Assessment | Potentially related to procedure, device or drug |
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| Tube occlusion | Ear and labyrinth disorders | Systematic Assessment | Potentially related to procedure, device or drug |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment | Not related to procedure, device or drug |
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| Otorrhea | Ear and labyrinth disorders | Systematic Assessment | Not related to procedure, device or drug |
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| Incontinence | Renal and urinary disorders | Systematic Assessment | Not related to procedure, device or drug |
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| Change in respiration rate | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to procedure, device or drug. Per protocol, required to report any change in respiration > 30% as an adverse event. These events were not clinically significant and within normal range. |
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PI must submit communications to Sponsor for review and comment to verify accurate content at least 30 days prior to submitting to any third party. A delay up to 90 days may be requested by Sponsor in order to file patent applications relating to an Invention if applicable. Sponsor and PI agree that any Institution Publication shall only be made after the Multicenter Publication, provided that the Multicenter Publication is submitted within 18 months after conclusion of the study at all sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura England, PhD | Tusker Medical | (650) 223-6909 | lengland@tuskermed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2017 | Dec 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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