Hummingbird TTS Ear Tube Delivery Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-009142
NCT ID: NCT02165384
Sponsor Protocol Number: 13-009142
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Shelagh Cofer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available