NCT03544138

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
3 months until next milestone

Results Posted

Study results publicly available

December 14, 2022

Completed
Last Updated

December 14, 2022

Status Verified

November 1, 2022

Enrollment Period

4.1 years

First QC Date

May 9, 2018

Results QC Date

September 22, 2022

Last Update Submit

November 18, 2022

Conditions

Ear InfectionOtitis Media

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Intra-procedure

Study Arms (1)

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.

Device: Hummingbird Tympanostomy Tube System (H-TTS)

Interventions

Hummingbird Tympanostomy Tube System (H-TTS)DEVICE

The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

Also known as: H-TTS
Hummingbird Tympanostomy Tube System (H-TTS)

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cedars-Sinai Medical Care Foundation

Beverly Hills, California, 90211, United States

Location

Children's Ear Nose Throat & Allergy

Orlando, Florida, 32835, United States

Location

HealthPartners Institute

Bloomington, Minnesota, 55425-4516, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Cloud Ear, Nose & Throat

Saint Cloud, Minnesota, 56303, United States

Location

Park Nicollet

Saint Louis Park, Minnesota, 55416, United States

Location

Prairie Sinus Ear & Allergy, P.C.

Bismarck, North Dakota, 58503-0697, United States

Location

Related Publications (1)

  • 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.

    PMID: 33869765DERIVED

Related Links

MeSH Terms

Conditions

OtitisOtitis Media

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Steve Anderson
Organization
Preceptis Medical
steve@preceptismedical.com
612-327-4795

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 1, 2018

Study Start

July 24, 2018

Primary Completion

September 6, 2022

Study Completion

September 12, 2022

Last Updated

December 14, 2022

Results First Posted

December 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available to other researchers.

Locations

US(7)