AOM - Acute Otitis Media, Barotrauma;Ear, Eustachian Tube Dysfunction, OME - Otitis Media With Effusion
Conditions
Brief summary
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).
Detailed description
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.
Interventions
COMBINATION_PRODUCTTymbion Iontophoresis and Tube Delivery System (TDS)
Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.
Sponsors
Tusker Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults at least 18 years of age at time of consent 2. Indication for tympanostomy tube insertion per Clinical Practice Guideline,or indicated for tympanostomy tube insertion due to barotrauma or Eustachian tube dysfunction per AAO-HNS Clinical Indicators. 3. Subject is able and willing to comply with the protocol and attend all study visits. 4. Subject is able and willing to provide informed consent. 5. Subject is able to read and understand English.
Exclusion criteria
by Ear: 1. Significantly atrophic, retracted or retraction pocket at location of tube placement, bimeric, monomeric or atelectatic tympanic membrane. 2. Perforated tympanic membrane. 3. Otitis externa. 4. Hemotympanum. 5. Damaged/denuded skin in the auditory canal. 6. 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. 7. Notable ear discomfort experienced during audiologic or otoscopic examination. 8. Anatomy that precludes sufficient visualization of and access to the tympanic membrane. 9. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. | Day of procedure (Day 0)- Immediately after tube placement | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Tubes not placed | 1 |
Baseline characteristics
| Characteristic | Tube Insertion Using Tube Delivery System (TDS) |
|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 15.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 10 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Day of procedure (Day 0)- Immediately after tube placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tube Insertion Using Tube Delivery System (TDS) | Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. | 9.4 millimeters | Standard Deviation 15.7 |
Comparison: Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.