Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Tube insertion using Tube Delivery System (TDS) Active Tymbion iontophoresis and tube insertion using the TDS |
Combination Product: Tymbion 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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults at least 18 years of age at time of consent
-
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.
-
Subject is able and willing to comply with the protocol and attend all study visits.
-
Subject is able and willing to provide informed consent.
-
Subject is able to read and understand English.
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sacramento ENT | Roseville | California | United States | 95661 |
| 2 | Camino ENT | San Jose | California | United States | 95138 |
| 3 | Advanced ENT and Allergy | Louisville | Kentucky | United States | 40207 |
| 4 | Charlotte Eye Ear Nose and Throat Associates | Charlotte | North Carolina | United States | 28105 |
| 5 | Specialty Physician Associates | Bethlehem | Pennsylvania | United States | 18017 |
| 6 | South Carolina ENT | Lugoff | South Carolina | United States | 29078 |
| 7 | Carolina Ear, Nose and Throat | Orangeburg | South Carolina | United States | 29118 |
| 8 | Ear Medical Group | San Antonio | Texas | United States | 78240 |
Sponsors and Collaborators
- Tusker Medical
Investigators
- Principal Investigator: David Yen, MD, Specialty Physician Associates
Study Documents (Full-Text)
More Information
Publications
None provided.- CPR007003 - Group B
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tube Insertion Using Tube Delivery System (TDS) |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 30 |
| COMPLETED | 29 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Tube Insertion Using Tube Delivery System (TDS) |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 30 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.9
(15.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
56.7%
|
| Male |
13
43.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
3.3%
|
| Not Hispanic or Latino |
29
96.7%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
1
3.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
16.7%
|
| White |
21
70%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
10%
|
| Region of Enrollment (participants) [Number] | |
| United States |
30
100%
|
Outcome Measures
| Title | Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tube Insertion Using Tube Delivery System (TDS) |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 29 |
| Mean (Standard Deviation) [millimeters] |
9.4
(15.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tube Insertion Using Tube Delivery System (TDS) |
|---|---|---|
| Comments | Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance. | |
| Type of Statistical Test | Superiority | |
| Comments | Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Bootstrap method |
| Estimated Value | 14.35 | |
| Confidence Interval |
(1-Sided) 97.5% to 14.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Procedure through 3-week post-procedure follow-up visit. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Tube Insertion Using Tube Delivery System (TDS) | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Tube Insertion Using Tube Delivery System (TDS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Serious Adverse Events |
||
| Tube Insertion Using Tube Delivery System (TDS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Tube Insertion Using Tube Delivery System (TDS) | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/30 (33.3%) | |
| Ear and labyrinth disorders | ||
| Inadequate anesthesia | 1/30 (3.3%) | 1 |
| Ear discomfort | 1/30 (3.3%) | 1 |
| Tube in middle ear | 1/30 (3.3%) | 1 |
| Vertigo | 1/30 (3.3%) | 1 |
| Dizziness | 1/30 (3.3%) | 1 |
| Tube occlusion | 2/30 (6.7%) | 2 |
| Otorrhea | 1/30 (3.3%) | 1 |
| Metabolism and nutrition disorders | ||
| Dehydration | 1/30 (3.3%) | 1 |
| Renal and urinary disorders | ||
| Incontinence | 1/30 (3.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Change in respiration rate | 2/30 (6.7%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Laura England, PhD |
|---|---|
| Organization | Tusker Medical |
| Phone | (650) 223-6909 |
| lengland@tuskermed.com |
- CPR007003 - Group B