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This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.
The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBIONâ„¢ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tula Tympanostomy | Patients undergoing in-office tympanostomy using the Tula® System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iontophoresis and tube placement | Combination Product | Iontophoretic delivery of TYMBIONâ„¢ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | Count (and percentage) of patients with successful placement of Tula Tympanostomy Tubes in all indicated ears in an office procedure | Day of procedure (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability (physician reported) | Count (and percentage) of patients that tolerated the procedure acceptably as determined by physician's observation. | Day of procedure (day 0) |
| Tolerability (parent reported) - anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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Participating centers will invite eligible patients ages 6 months to 17 years of age indicated for tympanostomy to participate in the Registry
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine E Whittall, BsC, Ph.D | Contact | +44 7841 868997 | catherine.whittall@smith-nephew.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced ENT and Allergy | Recruiting | Louisville | Kentucky | 40220 | United States |
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Count (and percentage) of patients whose parents strongly agree or agree with the statement 'My child tolerated the anesthesia process well'
| Day of procedure (day 0) |
| Tolerability (parent reported) - procedure | Count (and percentage) of patients whose parents strongly agree or agree with the statement 'The tube placement portion of the procedure was tolerable for my child'. | Day of procedure (day 0) |
| Recovery (physician reported) | Count (and percentage) of patients who recovered once back with parent, or prior to leaving the clinic, following procedure completion as determined by physician's observation. | Day of procedure (day 0) |
| Recovery (parent reported) | Count (and percentage) of patients who returned to normal activities immediately following the procedure. | Day of procedure (day 0) |
| Anesthesia effectiveness - patients | Count (and percentage) of patients who completed iontophoresis with adequate anesthesia for tube placement in all treated ears as determined by the physician's evaluation of tympanic membrane anesthesia | Day of procedure (day 0) |
| Anesthesia effectiveness - ears | Count (and percentage) of ears that completed iontophoresis with adequate anesthesia for TT placement as determined by the physician's tympanic membrane anesthesia evaluation. | Day of procedure (day 0) |
| Tula Tympanostomy Tube retention | Count (and percentage) of patients at the first post-operative visit in which a Tula Tympanostomy Tube was successfully placed, with presence of the Tula Tympanostomy Tube across the tympanic membrane | 1 month post procedure |
| Parent satisfaction (informed) | Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'I felt well informed and prepared to help me/my child complete the procedure' | 1 month post-procedure |
| Parent satisfaction (siblings) | Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'If my child had a sibling who needed ear tubes, I would choose this procedure in the office instead of going under general anesthesia in the operating room' | 1 month post-procedure |
| Overall parent satisfaction | Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'Overall, I am very satisfied with the in-office ear tube procedure' | 1 month post-procedure |
| Parent satisfaction (recommendation) | Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'I would recommend this procedure to family/friends who have children who need ear tubes' | 1 month post-procedure |
| Regional Otolaryngology Head and Neck Associates | Recruiting | Cherry Hill | New Jersey | 08034 | United States |
|
| Rutgers Robert Wood Johnson Medical School | Recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| Columbia University Vagelos College of Physicians and Surgeons | Recruiting | New York | New York | 10032 | United States |
|
| Ogden Clinic - Professional Center North | Recruiting | Ogden | Utah | 84403 | United States |
|
| Peak Pediatric Ear, Nose and Throat | Recruiting | Provo | Utah | 84604 | United States |
|
| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D007478 | Iontophoresis |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004586 | Electrophoresis |
| D055664 | Electrochemical Techniques |
| D008919 | Investigative Techniques |
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