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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes 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.
  • Site IRB
    • Rochester, Minnesota: 18-003212
    NCT ID: NCT03544138
    Sponsor Protocol Number: NCT03544138

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. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Scheduled to undergo tympanostomy tube insertion in the clinic. 
  • Ages ≥6 months through ≤18 months or ≥5 years through ≤12 years.
  • 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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Shelagh Cofer, M.D.

Open for enrollment

Contact information:

Nicole Tombers R.N., CCRP

(507)538-9658

Tombers.Nicole@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20439263

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