Cerumen Impaction of Both EarsNCT04094116
Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial.
A study testing ear wax syringing without pre ear oil treatment in people with Cerumen Impaction of Both Ears, run by Hospital Authority, Hong Kong at 3 sites in Hong Kong.
Trial summary
Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cerumen Impaction of Both Ears
- What is being tested?
- ear wax syringing without pre ear oil treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesHong Kong
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years old, who complain about blocked ear found to have ear wax which impacts ear drum and able to sign consent.
Who cannot join
- Patients who are contraindicated to ear syringing will be excluded : otitis externa , otitis media , history of tympanic membrane perforation , history or ear surgery , unilateral deafness , in-co-operated patient (eg. Children ) , history of vertigo after ear syringing .
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Fanling Family MEdicine Centre , 1/F , 2 , Pik Fung Road , Fan Ling
Hong Kong, 852
Chang Wells, 97506274, wellschang@hotmail.com
Tai Po Jockey Club Clinic , 37 Ting Kok Road , Tai Po , Hong Kong
Hong Kong, 852
Chang Wells, wellschang@hotmail.com
Wong Siu Ching Family Medicine centre . 1 , Po Wu Lane , Tai Po
Hong Kong, 852
Chang Wells, 97506274, wellschang@hotmail.com
About this study
Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .
Read the detailed description
Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts, subjective improvement in hearing , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .
- Conditions
- Cerumen Impaction of Both Ears
- Being tested
- ear wax syringing without pre ear oil treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ear wax syringing without pre ear oil treatmentProcedure or surgery
Also called ear wax syringing with pre ear oil treatment
Active Comparator: ear wax syringing with pre ear oil treatment Sham Comparator: ear wax syringing without pre ear oil treatment
| Study group | Role | What they receive |
|---|---|---|
| ear wax syringing with pre ear oil treatment | Active comparator | patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. Receives: Procedure: ear wax syringing without pre ear oil treatment |
| ear wax syringing without pre ear oil treatment | Sham comparator | Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. Receives: Procedure: ear wax syringing without pre ear oil treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of syringing attempts (50 ml syringe)
For both groups the mean number of syringing attempts (and 95% confidence interval) is calculated and compared by testing the difference between the means, using a t test for independent samples. For patients with persistent earwax in both ears , the mean number of syringing attempts needed for both ears in one patient is used for the calculations . All ears in which the wax is still persistent after another 10 syringing attempts are given a value of 11 in the calculations . Data for this study is analyzed using SPSS version 26 .
Measured: 1 day
Secondary outcomes (1)
The presence of ear canal abrasion,
The presence of ear canal abrasion,
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerumen Impaction of Both EarsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non randomised control trials
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chang Wells, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094116
- Sponsor's protocol ID
- WON-20190902-11381
- Status last verified
- Sep 2019
- First submitted
- 14 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eekhof JA, de Bock GH, Le Cessie S, Springer MP. A quasi-randomised controlled trial of water as a quick softening agent of persistent earwax in general practice. Br J Gen Pract. 2001 Aug;51(469):635-7.
PubMed 11510392
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04094116
- Acronym / sponsor ID
- WON-20190902-11381
- Conditions
- Cerumen Impaction of Both Ears
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Sep 2019 (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.
Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .
Detailed description
Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts, subjective improvement in hearing , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non randomised control trials
| Arm | Type | Receives |
|---|---|---|
| ear wax syringing with pre ear oil treatment | Active comparator | Procedure: ear wax syringing without pre ear oil treatmentpatients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. |
| ear wax syringing without pre ear oil treatment | Sham comparator | Procedure: ear wax syringing without pre ear oil treatmentPatients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years old, who complain about blocked ear found to have ear wax which impacts ear drum and able to sign consent.
Key exclusion criteria (1 listed)
- Patients who are contraindicated to ear syringing will be excluded : otitis externa , otitis media , history of tympanic membrane perforation , history or ear surgery , unilateral deafness , in-co-operated patient (eg. Children ) , history of vertigo after ear syringing .
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 |
|---|---|---|
| ear wax syringing without pre ear oil treatmentAlso: ear wax syringing with pre ear oil treatmentActive Comparator: ear wax syringing with pre ear oil treatment Sham Comparator: ear wax syringing without pre ear oil treatment | Procedure or surgery | ear wax syringing with pre ear oil treatment, ear wax syringing without pre ear oil treatment |
Primary outcome
The mean number of syringing attempts (50 ml syringe)
Time frame: 1 day
For both groups the mean number of syringing attempts (and 95% confidence interval) is calculated and compared by testing the difference between the means, using a t test for independent samples. For patients with persistent earwax in both ears , the mean number of syringing attempts needed for both ears in one patient is used for the calculations . All ears in which the wax is still persistent after another 10 syringing attempts are given a value of 11 in the calculations . Data for this study is analyzed using SPSS version 26 .
1 secondary outcome
The presence of ear canal abrasion,
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Results publication: PubMed 11510392Eekhof JA, de Bock GH, Le Cessie S, Springer MP. A quasi-randomised controlled trial of water as a quick softening agent of persistent earwax in general practice. Br J Gen Pract. 2001 Aug;51(469):635-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ear wax syringing without pre ear oil treatment in people with Cerumen Impaction of Both Ears, run by Hospital Authority, Hong Kong at 3 sites in Hong Kong.
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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Wells (resident) (97506274, wellschang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean number of syringing attempts (50 ml syringe) (time frame: 1 day). 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 NCT04094116, which also lists 1 linked publication.
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 18 Sep 2019.