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Completed

NCT Number: NCT04902963

What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?

Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.

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Key information

Conditions

Eustachian Tube Dysfunction Ear Diseases Endolymphatic Hydrops Hearing Disorders Hearing Loss Hearing Loss, Sudden Labyrinth Diseases Meniere Disease Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Sudden Hearing Loss

Age range

26 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15 patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube. IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS. Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was obtained and each participating clinician completed the NIH training for "Protecting Human Research Participants".

14 patients (15 ears) were enrolled in this study and were examined by 2 independent examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete resorption were documented by each examiner. There were no adverse reactions. This pilot study suggests that there is utility for a bioabsorbable ear tube made from gelatin material, as the device was found to break down over the expected time frame and remained functional long enough to have clinical utility.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)

Exclusion criteria

  • none

Treatment and study plan

PE tube

Device

Gelatin mixed with antibiotic and steroid ear drop to create a rigid device that maintains a lumen, acting as an intermediate-duration bioabsorbable ear tube.

Primary outcomes

  1. Number of weeks that ventilation tube lumen is patent.

    Time frame: 0-3 months

    Primary outcome was presence of a lumen, reflecting a functional device.

Secondary outcomes

  1. Number of weeks until ventilation tube is fully resorbed.

    Time frame: 0-3 months

    Gelatin has been used in this site as packing material and has been shown to resorb over a period of several weeks. Full resorption of this device is expected.

Sponsors and collaborators

Lead sponsor

Skovlund Medical Products, LLC

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 26, 2021
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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