Otitis MediaNCT02165384
Hummingbird TTS Ear Tube Delivery Study
A study testing Ear tube placement with the Hummingbird TTS in people with Otitis Media, run by Preceptis Medical, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Otitis Media
- What is being tested?
- Ear tube placement with the Hummingbird TTS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2014to 1 Mar 2018
- 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled to undergo tympanostomy tube insertion.
- At least 6 months old.
- Subject is able and willing to comply with follow-up requirements.
- Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.
Who cannot join
- Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
- Significantly atrophic tympanic membrane.
- Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
- Anatomy precludes sufficient visualization and access to the tympanic membrane.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Fairview Maple Grove Surgery Center
Maple Grove, Minnesota, 55369
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
Read the detailed description
The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.
- Conditions
- Otitis Media
- Being tested
- Ear tube placement with the Hummingbird TTS
- 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.
Ear tube placement with the Hummingbird TTSDevice
Also called Preceptis Medical, Inc. Tympanostomy Tube Introducer System, Hummingbird Tympanostomy Tube Delivery System, Hummingbird TTS
Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
| Study group | Role | What they receive |
|---|---|---|
| Hummingbird TTS | Experimental | Ear tube placement with the Hummingbird TTS Receives: Device: Ear tube placement with the Hummingbird TTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.
Measured: intra operative
Number of Participants With Intra-operative Adverse Events
Any intra-operative adverse events, anticipated or unanticipated
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJan 2014
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Preceptis Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Rimell, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165384
- Sponsor's protocol ID
- Preceptis Alpha
- Status last verified
- Dec 2018
- First submitted
- 12 Jun 2014
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer
- ClinicalTrials.gov ID
- NCT02165384
- Acronym / sponsor ID
- Preceptis Alpha
- Conditions
- Otitis Media
- Keywords
- tympanostomy, myringotomy, otitis media, ear tubes, ear infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Preceptis Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
Detailed description
The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hummingbird TTS | Experimental | Device: Ear tube placement with the Hummingbird TTSEar tube placement with the Hummingbird TTS |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to undergo tympanostomy tube insertion.
- At least 6 months old.
- Subject is able and willing to comply with follow-up requirements.
- Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.
Key exclusion criteria (4 listed)
- Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
- Significantly atrophic tympanic membrane.
- Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
- 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 |
|---|---|---|
| Ear tube placement with the Hummingbird TTSAlso: Preceptis Medical, Inc. Tympanostomy Tube Introducer System, Hummingbird Tympanostomy Tube Delivery System, Hummingbird TTSUsing the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass. | Device | Hummingbird TTS |
Primary outcome
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
Time frame: intra operative
Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.
Number of Participants With Intra-operative Adverse Events
Time frame: Intra-operative
Any intra-operative adverse events, anticipated or unanticipated
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Otitis Media
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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.
Frank Rimell, MD principal investigator
Children's Hospitals and Clinics of Minnesota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ear tube placement with the Hummingbird TTS in people with 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 4 inclusion and 4 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 3 Jan 2019. 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 3 Jan 2019). 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 Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane (time frame: intra operative). The study lists 2 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 3 Jan 2019.