Study of the Hummingbird TTS™ Tympanostomy Tube System

NCT ID: NCT03503591

Last Updated: 2022-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-29

Study Completion Date

2021-08-31

Brief Summary

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The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.

Detailed Description

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The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.

Conditions

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Otitis Media

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Hummingbird Tympanostomy Tube System

Insertion of a ventilation tube under sedation and local anesthetic

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 6 months through 5 years of age
* Candidates for ventilation tube placement
* H-TTS used under moderate sedation and local anesthetic
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Preceptis Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

St. Cloud Ear, Nose & Throat

Saint Cloud, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Preceptis PMS

Identifier Type: -

Identifier Source: org_study_id

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