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

Sponsor

Skovlund Medical Products, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT04902963

Collaborator

(none)

Enrollment

Arm

7.6

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Eustachian Tube Dysfunction Sudden Hearing Loss Meniere Disease	Device: PE tube	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

14 patients underwent placement of a novel absorbable ventilation tube to test utility of this prototype device and monitor resorption over a period of weeks. 14 participants were approved for this study of feasibility to allow for patients who did not follow up per the study protocol.14 patients underwent placement of a novel absorbable ventilation tube to test utility of this prototype device and monitor resorption over a period of weeks. 14 participants were approved for this study of feasibility to allow for patients who did not follow up per the study protocol.

Masking:

None (Open Label)

Masking Description:

2 examiners used otomicroscopy to document the function of the ear tube by documenting the number of weeks the lumen remained patent and the number of weeks until the device was fully resorbed. All examiners documented results independent of the other examiner.