Back to resultsWhat is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
Primary Purpose
Eustachian Tube Dysfunction, Sudden Hearing Loss, Meniere Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PE tube
Sponsored by
About this trial
This is an interventional device feasibility trial for Eustachian Tube Dysfunction
Eligibility Criteria
Inclusion Criteria:
- meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)
Exclusion Criteria:
- none
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Meeting indication for short term ventilation tube placement
Arm 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.
Outcomes
Primary Outcome Measures
Number of weeks that ventilation tube lumen is patent.
Primary outcome was presence of a lumen, reflecting a functional device.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04902963
First Posted
April 1, 2021
Last Updated
May 20, 2021
Sponsor
Skovlund Medical Products, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04902963
Brief Title
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
Official Title
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2011 (Actual)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skovlund Medical Products, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction, Sudden Hearing Loss, Meniere Disease
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
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.
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meeting indication for short term ventilation tube placement
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
PE tube
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of weeks that ventilation tube lumen is patent.
Description
Primary outcome was presence of a lumen, reflecting a functional device.
Time Frame
0-3 months
Secondary Outcome Measure Information:
Title
Number of weeks until ventilation tube is fully resorbed.
Description
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.
Time Frame
0-3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
26 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Walker
Organizational Affiliation
Park Nicollet Institute, IRB Administrator
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
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