Perforation of Eardrum.NCT02000843
Tympanoplasty Using Conchal Cavum Approach and Conchal Pericondrium
A study testing tympanoplasty -- conchal cavum approach in people with Perforation of Eardrum., run by University of British Columbia at 1 site in Canada.
Trial summary
Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to repair broken eardrums. The Heermann approach is a well recognized procedure, in common clinical practise for years. The new approach has been used in patients after informed consent was obtained from each patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perforation of Eardrum.
- What is being tested?
- tympanoplasty -- conchal cavum approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with informed consent
Who cannot join
- Patients without consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tympanoplasty -- Conchal Cavum Approach
Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to repair broken eardrums. The Heermann approach is a well recognized procedure, in common clinical practise for years.
The new approach has been used in patients after informed consent was obtained from each patient.
Read the detailed description
From 2010 to 2013, a total of 96 patients had the procedure. The data are entered, and analyzed. All identifiable information would be hidden.
This application is to obtain patients' consent for release and publication of the data. Patients would be assured their identities are protected.
- Conditions
- Perforation of Eardrum.
- Being tested
- tympanoplasty -- conchal cavum approach
- Keywords
- perforation, tympanoplasty, conchal cavum approach, perichondrium/ cartilage, scar
- Medical subject headings
- Tympanic Membrane Perforation, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tympanoplasty -- conchal cavum approachProcedure or surgery
Incision is made inside the ear canal. It is extended into the conchal cavum. The incision allows a direct approach to the eardrum, and also allow easy harvesting of the perichondrium to be used as graft material.
| Study group | Role | What they receive |
|---|---|---|
| perichondrium graft perforation | Other | tympanoplasty -- conchal cavum approach is used. Receives: Procedure: tympanoplasty -- conchal cavum approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of repair of eardrum
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perforation of Eardrum.Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Man, MD FRCS(C), Principal investigator, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000843
- Sponsor's protocol ID
- H13-03261
- Status last verified
- Oct 2014
- First submitted
- 27 Nov 2013
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohamad SH, Khan I, Hussain SS. Is cartilage tympanoplasty more effective than fascia tympanoplasty? A systematic review. Otol Neurotol. 2012 Jul;33(5):699-705. doi: 10.1097/MAO.0b013e318254fbc2.
PubMed 22643445Man SC, Nunez DA. Tympanoplasty--conchal cavum approach. J Otolaryngol Head Neck Surg. 2016 Jan 6;45:1. doi: 10.1186/s40463-015-0113-3.
PubMed 26739478
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tympanoplasty -- Conchal Cavum Approach
- ClinicalTrials.gov ID
- NCT02000843
- Acronym / sponsor ID
- H13-03261
- Conditions
- Perforation of Eardrum.
- Keywords
- perforation, tympanoplasty, conchal cavum approach, perichondrium/ cartilage, scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Dec 2013 (estimated)
- 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.
Tympanoplasty -- conchal cavum approach is a modification of Heermann endural approach to repair broken eardrums. The Heermann approach is a well recognized procedure, in common clinical practise for years.
The new approach has been used in patients after informed consent was obtained from each patient.
Detailed description
From 2010 to 2013, a total of 96 patients had the procedure. The data are entered, and analyzed. All identifiable information would be hidden.
This application is to obtain patients' consent for release and publication of the data. Patients would be assured their identities are protected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| perichondrium graft perforation | Other | Procedure: tympanoplasty -- conchal cavum approachtympanoplasty -- conchal cavum approach is used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with informed consent
Key exclusion criteria (1 listed)
- Patients without consent
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 |
|---|---|---|
| tympanoplasty -- conchal cavum approachIncision is made inside the ear canal. It is extended into the conchal cavum. The incision allows a direct approach to the eardrum, and also allow easy harvesting of the perichondrium to be used as graft material. | Procedure or surgery | perichondrium graft perforation |
Primary outcome
success rate of repair of eardrum
Time frame: one year
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 3 Oct 2014.
- Background: PubMed 22643445Mohamad SH, Khan I, Hussain SS. Is cartilage tympanoplasty more effective than fascia tympanoplasty? A systematic review. Otol Neurotol. 2012 Jul;33(5):699-705. doi: 10.1097/MAO.0b013e318254fbc2.
- Derived from this study: PubMed 26739478Man SC, Nunez DA. Tympanoplasty--conchal cavum approach. J Otolaryngol Head Neck Surg. 2016 Jan 6;45:1. doi: 10.1186/s40463-015-0113-3.
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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.
Christopher Man, MD FRCS(C) principal investigator
UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tympanoplasty -- conchal cavum approach in people with Perforation of Eardrum., run by University of British Columbia at 1 site in Canada.
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 3 Oct 2014. 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 Canada. 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.
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?
success rate of repair of eardrum (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02000843, which also lists 2 linked publications.
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 3 Oct 2014.