TympanosclerosisPhase 1NCT05497934
The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
A Phase 1 study testing Glycerol in people with Tympanosclerosis and Thickened Ears, run by Nova Scotia Health Authority.
Trial summary
This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tympanosclerosis, Thickened Ears, Healthy
- What is being tested?
- Glycerol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 31 Mar 2024
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Thickened tympanic membrane (e.g. due to fibrosis) x10
- Tympanosclerosis of the tympanic membrane x10
- History of middle ear surgery with partial or total ossicular replacement prosthesis and cartilage tympanoplasty x10
- History of cartilage tympanoplasty without prosthesis implantation x10
- Normal tympanic membrane without history of middle ear disease x10
Who cannot join
- Narrow or stenotic external auditory canal that prevents visualization of the tympanic membrane
- Mobility disorder that prevents patient from remaining still during imaging
- Perforation of the tympanic membrane
- Open sores or infections of the external auditory canal
About this study
This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears
Read the detailed description
This study will explore whether the utility of Optical Coherence Tomography (OCT) in otology patients can be enhanced through the application of topical glycerol as an optical clearing agent in patients with normal, opaque and post operative tympanic membranes. In each group of subjects, a comparison will be made between OCT images obtained before and after the topical application of glycerol to the tympanic membrane and following washout with saline. Images will also be assessed for their diagnostic utility as determined by the visibility of key structures and the change in middle ear mobility caused by glycerol absorption in the tympanic membrane.
- Conditions
- Tympanosclerosis, Thickened Ears, Healthy, Surgery
- Being tested
- Glycerol
- Medical subject headings
- Tympanosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycerolDrug
Also called Glycerin(e)
In this study, 99.5% pure glycerol will be used as an optical clearing agent. The glycerol will be applied topically to the tympanic membrane.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Subjects will be imaged with OCT and endoscopy before treatment of the tympanic membrane with topical glycerol, after treatment of the tympanic membrane with topical glycerol and after rinsing the tympanic membrane with saline Receives: Drug: Glycerol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in optical attenuation rate of the tympanic membrane
Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions
Measured: 20 minutes
Secondary outcomes (2)
Change in acoustic mobility of the umbo
Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions
Measured: 20 minutes
Change in B-mode signal-to-noise ratio of the cochlear promontorium
Change in the B-mode signal-to-noise ratio for a region of interest on the cochlear promontorium distal to the tympanic membrane between pre- and post-treatment conditions
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Why it stopped: No response from initial letter or expiry email- closed by REB office
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TympanosclerosisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will undergo OCT and conventional endoscopic imaging before topical application of glycerol to the tympanic membrane, after topical application of glycerol to the tympanic membrane and after rinsing the tympanic membrane with saline.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor
- Investigators
- David P Morris, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497934
- Sponsor's protocol ID
- 1028201
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of trial will be published in a journal article
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
- ClinicalTrials.gov ID
- NCT05497934
- Acronym / sponsor ID
- 1028201
- Conditions
- Tympanosclerosis, Thickened Ears, Healthy, Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No response from initial letter or expiry email- closed by REB office
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 11 Aug 2022 (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.
This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears
Detailed description
This study will explore whether the utility of Optical Coherence Tomography (OCT) in otology patients can be enhanced through the application of topical glycerol as an optical clearing agent in patients with normal, opaque and post operative tympanic membranes. In each group of subjects, a comparison will be made between OCT images obtained before and after the topical application of glycerol to the tympanic membrane and following washout with saline. Images will also be assessed for their diagnostic utility as determined by the visibility of key structures and the change in middle ear mobility caused by glycerol absorption in the tympanic membrane.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will undergo OCT and conventional endoscopic imaging before topical application of glycerol to the tympanic membrane, after topical application of glycerol to the tympanic membrane and after rinsing the tympanic membrane with saline.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: GlycerolSubjects will be imaged with OCT and endoscopy before treatment of the tympanic membrane with topical glycerol, after treatment of the tympanic membrane with topical glycerol and after rinsing the tympanic membrane with saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Thickened tympanic membrane (e.g. due to fibrosis) x10
- Tympanosclerosis of the tympanic membrane x10
- History of middle ear surgery with partial or total ossicular replacement prosthesis and cartilage tympanoplasty x10
- History of cartilage tympanoplasty without prosthesis implantation x10
- Normal tympanic membrane without history of middle ear disease x10
Key exclusion criteria (4 listed)
- Narrow or stenotic external auditory canal that prevents visualization of the tympanic membrane
- Mobility disorder that prevents patient from remaining still during imaging
- Perforation of the tympanic membrane
- Open sores or infections of the external auditory canal
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 |
|---|---|---|
| GlycerolAlso: Glycerin(e)In this study, 99.5% pure glycerol will be used as an optical clearing agent. The glycerol will be applied topically to the tympanic membrane. | Drug | Treatment arm |
Primary outcome
Change in optical attenuation rate of the tympanic membrane
Time frame: 20 minutes
Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions
2 secondary outcomes
Change in acoustic mobility of the umbo
Time frame: 20 minutes
Change in B-mode signal-to-noise ratio of the cochlear promontorium
Time frame: 20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No. Results of trial will be published in a journal article
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.
David P Morris, MD principal investigator
Nova Scotia Health Authority
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycerol in people with Tympanosclerosis and Thickened Ears, run by Nova Scotia Health Authority.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 21 Aug 2024. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in optical attenuation rate of the tympanic membrane (time frame: 20 minutes). 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 21 Aug 2024.