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

Skovlund Medical Products

Status: Completed

Conditions: Meniere Disease; Sudden Hearing Loss; Eustachian Tube Dysfunction

Treatments: Device: PE tube

Study type: Interventional

Funder types: Other

Identifiers

NCT04902963

04053-10-C

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 26 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Meeting indication for short term ventilation tube placement

Experimental group

Description:

Adult patients meeting standard criteria for short-term ventilation tube placement were offered placement of a bioabsorbable ear tube in place of a durable ear tube that would later be removed.

Treatment:

Device: PE tube