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NCT03544138 · ClinicalTrials.gov registry record · NA

In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old

A NA study of Otitis Media and Ear Infection, sponsored by Preceptis Medical.

Completed
Registry status
NA
Development phase
258
Enrollment target
7
Study locations

NCT03544138 is a NA study of Otitis Media and Ear Infection that has completed, run by Preceptis Medical. The registered enrollment target is 258 participants, below the 4,325-participant average among 14 other Otitis Media trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 4 states.

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The verdict

NCT03544138, a NA study of Otitis Media and Ear Infection, has completed, sponsored by Preceptis Medical.

COMPLETED
Registry status
NA
Development phase
258 participants
Enrollment target
7
Study locations

Study 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.

Interventions

  • DEVICE Hummingbird Tympanostomy Tube System (H-TTS)

Study Locations (7)

Minnesota

  • HealthPartners Institute - Bloomington
  • Mayo Clinic - Rochester
  • St. Cloud Ear, Nose & Throat - Saint Cloud
  • Park Nicollet - Saint Louis Park

California

  • Cedars-Sinai Medical Care Foundation - Beverly Hills

Florida

  • Children's Ear Nose Throat & Allergy - Orlando

North Dakota

  • Prairie Sinus Ear & Allergy, P.C. - Bismarck

Trial Details

FieldValue
Enrollment Target 258 participants
Start Date 2018-07-24
Est. Completion 2022-09-12
Phase NA

Sponsor

Preceptis Medical

3 total trials

What the Registry Record Tells You About NCT03544138

The ClinicalTrials.gov registry entry for NCT03544138 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,325-participant average among 14 other Otitis Media trials with a reported enrollment target (94% lower). The listed sponsor is Preceptis Medical, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Otitis Media appearing as the primary indexed condition, and to 1 intervention - of which Hummingbird Tympanostomy Tube System (H-TTS) is the first listed.

NCT03544138 reports 7 study locations spanning 4 distinct geographic areas - top geographies include Minnesota, California, Florida.

Frequently Asked Questions

What is clinical trial NCT03544138 about?

NCT03544138 is a clinical study titled "In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old". 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.

What is the current status of trial NCT03544138?

This trial is currently completed. It is a NA study. The enrollment target is 258 participants. The study started on 2018-07-24. Estimated completion is 2022-09-12.

What conditions does trial NCT03544138 study?

This clinical trial studies the following conditions: Otitis Media, Ear Infection.

What interventions are being tested in trial NCT03544138?

The interventions under investigation include: Hummingbird Tympanostomy Tube System (H-TTS) (DEVICE).

Who is sponsoring clinical trial NCT03544138?

This trial is sponsored by Preceptis Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03544138 being conducted?

This trial has 7 study locations across California, Florida, Minnesota, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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