Ear InfectionNCT03544138
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
A study testing Hummingbird Tympanostomy Tube System (H-TTS) in people with Ear Infection and Otitis Media, run by Preceptis Medical, Inc. at 7 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Ear Infection, Otitis Media
- What is being tested?
- Hummingbird Tympanostomy Tube System (H-TTS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Jul 2018to 12 Sep 2022
- Phase
- Interventional
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Scheduled to undergo tympanostomy tube insertion in the clinic.
- Children 6 months to 21 years old
- Signed parental consent, and child assent documents as applicable.
- Parent is fluent in English.
Who cannot join
- Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).
- Anatomy precludes sufficient visualization and access to the tympanic membrane.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cedars-Sinai Medical Care Foundation
Beverly Hills, California, 90211
Prairie Sinus Ear & Allergy, P.C.
Bismarck, North Dakota, 58503-0697
HealthPartners Institute
Bloomington, Minnesota, 55425-4516
Children's Ear Nose Throat & Allergy
Orlando, Florida, 32835
Mayo Clinic
Rochester, Minnesota, 55905
St. Cloud Ear, Nose & Throat
Saint Cloud, Minnesota, 56303
Park Nicollet
Saint Louis Park, Minnesota, 55416
About this study
Official title: Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic
The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.
Read the detailed description
The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for children. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.
The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children.
Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube.
- Conditions
- Ear Infection, Otitis Media
- Being tested
- Hummingbird Tympanostomy Tube System (H-TTS)
- Medical subject headings
- Otitis, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hummingbird Tympanostomy Tube System (H-TTS)Device
Also called H-TTS
The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) | Other | The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. Receives: Device: Hummingbird Tympanostomy Tube System (H-TTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up
AEs that occurred from enrollment through the 3-10 week follow-up were collected.
Measured: Follow-up between 3-10 weeks
Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS
Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.
Measured: Intra-Procedure
Percentage of Participants With Successful Completion of Procedure In-office
Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic.
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start24 Jul 2018
- Primary completion6 Sep 2022
- Study completion12 Sep 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ear InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 258 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
- NCT03544138
- Sponsor's protocol ID
- Preceptis Pivotal
- Status last verified
- Nov 2022
- First submitted
- 9 May 2018
- Last updated
- 14 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Publications
Truitt TO, Kosko JR, Nimmons GL, Raisen J, Skovlund SM, Rimell F, Cofer SA. In-office insertion tympanostomy tubes in children using single-pass device. Laryngoscope Investig Otolaryngol. 2021 Feb 2;6(2):325-331. doi: 10.1002/lio2.533. eCollection 2021 Apr.
PubMed 33869765
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic
- ClinicalTrials.gov ID
- NCT03544138
- Acronym / sponsor ID
- Preceptis Pivotal
- Conditions
- Ear Infection, Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Preceptis Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Posted 14 Dec 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 is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.
Detailed description
The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for children. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.
The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children.
Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) | Other | Device: Hummingbird Tympanostomy Tube System (H-TTS)The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Scheduled to undergo tympanostomy tube insertion in the clinic.
- Children 6 months to 21 years old
- Signed parental consent, and child assent documents as applicable.
- Parent is fluent in English.
Key exclusion criteria (2 listed)
- Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).
- Anatomy precludes sufficient visualization and access to the tympanic membrane.
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 System (H-TTS)Also: H-TTSThe H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure. | Device | Hummingbird Tympanostomy Tube System (H-TTS) |
Primary outcome
Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up
Time frame: Follow-up between 3-10 weeks
AEs that occurred from enrollment through the 3-10 week follow-up were collected.
Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS
Time frame: Intra-Procedure
Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.
Percentage of Participants With Successful Completion of Procedure In-office
Time frame: Intra-procedure
Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33869765Truitt TO, Kosko JR, Nimmons GL, Raisen J, Skovlund SM, Rimell F, Cofer SA. In-office insertion tympanostomy tubes in children using single-pass device. Laryngoscope Investig Otolaryngol. 2021 Feb 2;6(2):325-331. doi: 10.1002/lio2.533. eCollection 2021 Apr.
- Precepts Medical, Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hummingbird Tympanostomy Tube System (H-TTS) in people with Ear Infection and Otitis Media, run by Preceptis Medical, Inc. at 7 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 4 inclusion and 2 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 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 14 Dec 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?
Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up (time frame: Follow-up between 3-10 weeks). 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?
On the ClinicalTrials.gov record for NCT03544138, which also lists 1 linked publication.
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 14 Dec 2022.