Otitis Media
Conditions
Keywords
tympanostomy, myringotomy, otitis media, ear tubes, ear infection
Brief summary
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
Detailed description
The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.
Interventions
DEVICEHummingbird Tympanostomy Tube System
Insertion of a ventilation tube under sedation and local anesthetic
Sponsors
Preceptis Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Age 6 months through 5 years of age * Candidates for ventilation tube placement * H-TTS used under moderate sedation and local anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Procedures Converted From Sedation to General Anesthesia | Intra-operative | Percentage of procedures that require conversion from sedation to general anesthesia |
| Rate of Intra-operative Adverse Events | Intra-operative | Rate of intra-operative adverse events that occur from the beginning to the end of the procedure |
| Rate of Adverse Events Through Discharge | Through discharge, estimated to be approximately 90 minutes post-procedure | Rate of adverse events that occur between the end of the procedure and discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insertion of a Ventilation Tube Under Sedation and Local Anesthetic Children 6 months through 5 years of age, who are candidates for placement of VT. | 109 |
| Total | 109 |
Baseline characteristics
| Characteristic | Insertion of a Ventilation Tube Under Sedation and Local Anesthetic | — |
|---|---|---|
| Age, Continuous | 19 Months | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 109 participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 109 |
| other Total, other adverse events | 0 / 109 |
| serious Total, serious adverse events | 0 / 109 |
Outcome results
Primary
Percentage of Procedures Converted From Sedation to General Anesthesia
Percentage of procedures that require conversion from sedation to general anesthesia
Time frame: Intra-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insertion of a Ventilation Tube Under Sedation and Local Anesthetic | Percentage of Procedures Converted From Sedation to General Anesthesia | 12.8 percentage of procedures converted |
Primary
Rate of Adverse Events Through Discharge
Rate of adverse events that occur between the end of the procedure and discharge
Time frame: Through discharge, estimated to be approximately 90 minutes post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insertion of a Ventilation Tube Under Sedation and Local Anesthetic | Rate of Adverse Events Through Discharge | 0 percentage of AEs through discharge |
Primary
Rate of Intra-operative Adverse Events
Rate of intra-operative adverse events that occur from the beginning to the end of the procedure
Time frame: Intra-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insertion of a Ventilation Tube Under Sedation and Local Anesthetic | Rate of Intra-operative Adverse Events | 0 participants |