NCT04902963

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Skovlund Medical Products, LLC · Academic / Other
• Sex: All
• Age: 26 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Eustachian Tube Dysfunction
• Sudden Hearing Loss
• Meniere Disease

Interventions

Type	Name	Description
DEVICE	PE tube	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.

Timeline

• Start date: 2011-03-15
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2021-05-26
• Last updated: 2021-05-26