Eustachian Tube Dysfunction, Meniere Disease, Sudden Hearing Loss
Conditions
Brief 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.
Interventions
DEVICEPE 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.
Sponsors
Skovlund Medical Products, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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.
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.
Eligibility
Sex/Gender
ALL
Age
26 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of weeks that ventilation tube lumen is patent. | 0-3 months | Primary outcome was presence of a lumen, reflecting a functional device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of weeks until ventilation tube is fully resorbed. | 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. |
Outcome results
None listed