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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local anesthesia | Experimental | tympanic membrane local anesthesia delivery system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iontophoresis System (Acclarent) | Device | Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment | Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness. | Day 0 |
| Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale | Includes all subjects for whom Iontophoresis current delivery was initiated. The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. The Wong-Baker scores are reported by subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale. | The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry "Fritz" Butehorn, III, MD | Spartanburg ENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spartanburg ENT | Spartanburg | South Carolina | 29303 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iontophoretic Delivery of Local Anesthesia | Tympanic membrane anesthesia delivery system Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Day 0 |
| Subject/Parent Reported Satisfaction With the In-office Procedure | Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported. The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period. | Day 0 |
| Day 0 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Iontophoretic Delivery of Anesthesia | Tympanic membrane anesthesia delivery system Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine. |
| 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 |
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| Sex: Female, Male | 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 | Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment | Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 0 |
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| Secondary | Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale | Includes all subjects for whom Iontophoresis current delivery was initiated. The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. The Wong-Baker scores are reported by subject. | Analysis population includes subjects completing iontophoresis for which Wong Baker scores are available. | Posted | Mean | Standard Deviation | units on a scale | Day 0 |
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| Secondary | Subject/Parent Reported Satisfaction With the In-office Procedure | Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported. The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period. | Posted | Number | 95% Confidence Interval | % adult subjects or parents | Day 0 |
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| Other Pre-specified | Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale. | The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears. | Analysis population includes subjects who completed anesthesia and for which an ear procedure was attempted | Posted | Mean | Standard Deviation | units on a scale | Day 0 |
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| Primary | Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). | Posted | Number | participants | Day 0 |
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1 day (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 | Anesthesia | tympanic membrane anesthesia delivery system Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine. | 0 | 109 | 2 | 109 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Nervous system disorders | Systematic Assessment |
| ||
| Mild Erythema at return electrode | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Director | Acclarent | 650-687-5888 | lenglan1@its.jnj.com |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Categories |
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| Vertigo |
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| Mild erythema at return electrode |
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