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

Eustachian Tube Dysfunction Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Eustachian Tube Dysfunction
• Hearing Loss
• Hearing Loss, Sudden
• Meniere Disease
• Sudden Hearing Loss

• NCT number: NCT04902963
• Study type: Interventional
• Source: Skovlund Medical Products, LLC
• Status: Completed
• Phase: N/A
• Start date: March 15, 2011
• Completion date: November 2011