Tympanic Membrane PerforationPhase 1/2NCT03837665
Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation
A Phase 1/2 study testing Platelet Rich Plasma in people with Tympanic Membrane Perforation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Platelet Rich Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2018to 29 Oct 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet criteria for tympanoplasty procedure
- Willing to comply with the protocol and attend all study visits
- Able to provide written informed consent
Who cannot join
- Patients who have previously undergone middle ear or lateral skull base surgery
- Patients who would not qualify for a tympanoplasty
- Any type of platelet disorder, cancer, or ongoing systemic infection
- Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums
- Type I diabetes or other autoimmune pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Platelet Rich Plasma
- Keywords
- Platelet Rich Plasma, TM perforations, Hearing loss, Hole in the eardrum
- Medical subject headings
- Tympanic Membrane Perforation, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Also called PRP
Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.
| Study group | Role | What they receive |
|---|---|---|
| PRP Treatment | Experimental | Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise. Receives: Biological: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Patients Requiring Surgery
Number of participants that are able to avoid surgery for their perforation.
Measured: 6 Weeks
Secondary outcomes (1)
Time to Healing
Size of perforation
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start2 May 2018
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Why it stopped: Recruitment barriers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hinrich Staecker, MD, PhD, University of Kansas Medical Center
- Investigators
- Hinrich Staecker, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837665
- Sponsor's protocol ID
- STUDY00140843
- Status last verified
- Jun 2024
- First submitted
- 8 Feb 2019
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation
- ClinicalTrials.gov ID
- NCT03837665
- Acronym / sponsor ID
- STUDY00140843
- Conditions
- Tympanic Membrane Perforation
- Keywords
- Platelet Rich Plasma, TM perforations, Hearing loss, Hole in the eardrum
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment barriers
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP Treatment | Experimental | Biological: Platelet Rich PlasmaParticipants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who meet criteria for tympanoplasty procedure
- Willing to comply with the protocol and attend all study visits
- Able to provide written informed consent
Key exclusion criteria (5 listed)
- Patients who have previously undergone middle ear or lateral skull base surgery
- Patients who would not qualify for a tympanoplasty
- Any type of platelet disorder, cancer, or ongoing systemic infection
- Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums
- Type I diabetes or other autoimmune pathology
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 |
|---|---|---|
| Platelet Rich PlasmaAlso: PRPPlatelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets. | Biological | PRP Treatment |
Primary outcome
Prevention of Patients Requiring Surgery
Time frame: 6 Weeks
Number of participants that are able to avoid surgery for their perforation.
1 secondary outcome
Time to Healing
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hinrich Staecker, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet Rich Plasma in people with Tympanic Membrane Perforation, run by University of Kansas Medical Center at 1 site in United States.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevention of Patients Requiring Surgery (time frame: 6 Weeks). 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 16 Jul 2024.