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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2021
Source Skovlund Medical Products, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Skovlund Medical Products, LLC

Outcome

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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