Eustachian Tube DysfunctionNCT04902963
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
A study testing PE tube in people with Eustachian Tube Dysfunction and Sudden Hearing Loss, run by Skovlund Medical Products, LLC.
Trial summary
Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin. Read more about this study
- Who is it for?
- Ages 26 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Eustachian Tube Dysfunction, Sudden Hearing Loss, Meniere Disease
- What is being tested?
- PE tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)
Who cannot join
- none
About this study
Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.
Read the 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.
- Being tested
- PE tube
- Medical subject headings
- Hearing Loss, Sudden, Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PE tubeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Meeting indication for short term ventilation tube placement | Experimental | 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. Receives: Device: PE tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of weeks that ventilation tube lumen is patent.
Primary outcome was presence of a lumen, reflecting a functional device.
Measured: 0-3 months
Secondary outcomes (1)
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.
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start15 Mar 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skovlund Medical Products, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Skovlund, Skovlund Medical Products, LLC
- Investigators
- Tiffany Walker, Study director, Park Nicollet Institute, IRB Administrator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902963
- Sponsor's protocol ID
- 04053-10-C
- Status last verified
- May 2021
- First submitted
- 1 Apr 2021
- Last updated
- 26 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
- ClinicalTrials.gov ID
- NCT04902963
- Acronym / sponsor ID
- 04053-10-C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Skovlund Medical Products, LLCUniversity, hospital or other
- Study start
- 15 Mar 2011 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Meeting indication for short term ventilation tube placement | Experimental | Device: PE tubeAdult 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. |
Who may qualify
- Ages
- 26 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PE tubeGelatin mixed with antibiotic and steroid ear drop to create a rigid device that maintains a lumen, acting as an intermediate-duration bioabsorbable ear tube. | Device | Meeting indication for short term ventilation tube placement |
Primary outcome
Number of weeks that ventilation tube lumen is patent.
Time frame: 0-3 months
Primary outcome was presence of a lumen, reflecting a functional device.
1 secondary outcome
Number of weeks until ventilation tube is fully resorbed.
Time frame: 0-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Walker study director
Park Nicollet Institute, IRB Administrator
Questions about this trial
What is this clinical trial studying?
A study testing PE tube in people with Eustachian Tube Dysfunction and Sudden Hearing Loss, run by Skovlund Medical Products, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of weeks that ventilation tube lumen is patent. (time frame: 0-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.