Eustachian Tube Dysfunction Clinical Trial
Official title:
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
NCT number | NCT04902963 |
Other study ID # | 04053-10-C |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2011 |
Est. completion date | November 2011 |
Verified date | May 2021 |
Source | Skovlund Medical Products, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.
Status | Completed |
Enrollment | 14 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 26 Years to 80 Years |
Eligibility | Inclusion Criteria: - meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube) Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Skovlund Medical Products, LLC |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of weeks that ventilation tube lumen is patent. | Primary outcome was presence of a lumen, reflecting a functional device. | 0-3 months | |
Secondary | Number of weeks until ventilation tube is fully resorbed. | 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. | 0-3 months |
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