Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System in the Otolaryngology Clinic

Overview

About this study

The objective of this study is to evaluate the safety and performance of the H-TTS for the placement of ear tubes in patients undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.

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 in the clinic.
Children 2 to 21 years old.
Signed parental consent, and child assent documents as applicable.
Parent is fluent in English.

Exclusion Criteria:

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.

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

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

Clinical Trials