Otitis MediaNCT03503591
Study of the Hummingbird TTS™ Tympanostomy Tube System
An observational study of Otitis Media, run by Preceptis Medical, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Hummingbird Tympanostomy Tube System
- Type of treatment
- Medical device
- How many people
- 109 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Jan 2016to Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 6 months through 5 years of age, who are candidates for placement of VT.
Who may be able to join
- Age 6 months through 5 years of age
- Candidates for ventilation tube placement
- H-TTS used under moderate sedation and local anesthetic
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55409
University of Minnesota
Minneapolis, Minnesota, 55409
Mayo Clinic
Rochester, Minnesota, 55905
St. Cloud Ear, Nose & Throat
Saint Cloud, Minnesota, 56303
About this study
Official title: Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
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.
Read the 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.
- Conditions
- Otitis Media
- Being tested
- Hummingbird Tympanostomy Tube System
- Keywords
- tympanostomy, myringotomy, otitis media, ear tubes, ear infection
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hummingbird Tympanostomy Tube SystemDevice
Insertion of a ventilation tube under sedation and local anesthetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Procedures Converted From Sedation to General Anesthesia
Percentage of procedures that require conversion from sedation to general anesthesia
Measured: Intra-operative
Rate of Intra-operative Adverse Events
Rate of intra-operative adverse events that occur from the beginning to the end of the procedure
Measured: Intra-operative
Rate of Adverse Events Through Discharge
Rate of adverse events that occur between the end of the procedure and discharge
Measured: Through discharge, estimated to be approximately 90 minutes post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start29 Jan 2016
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Preceptis Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503591
- Sponsor's protocol ID
- Preceptis PMS
- Status last verified
- Oct 2022
- First submitted
- 2 Apr 2018
- Last updated
- 21 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
- ClinicalTrials.gov ID
- NCT03503591
- Acronym / sponsor ID
- Preceptis PMS
- Conditions
- Otitis Media
- Keywords
- tympanostomy, myringotomy, otitis media, ear tubes, ear infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Preceptis Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2016 (actual)
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 21 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 6 months through 5 years of age, who are candidates for placement of VT.
Key inclusion criteria (3 listed)
- Age 6 months through 5 years of age
- Candidates for ventilation tube placement
- H-TTS used under moderate sedation and local anesthetic
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hummingbird Tympanostomy Tube SystemInsertion of a ventilation tube under sedation and local anesthetic | Device | – |
Primary outcome
Percentage of Procedures Converted From Sedation to General Anesthesia
Time frame: Intra-operative
Percentage of procedures that require conversion from sedation to general anesthesia
Rate of Intra-operative Adverse Events
Time frame: 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
Time frame: Through discharge, estimated to be approximately 90 minutes post-procedure
Rate of adverse events that occur between the end of the procedure and discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media, run by Preceptis Medical, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Procedures Converted From Sedation to General Anesthesia (time frame: Intra-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.