Otitis Media With Effusion (OME)ST-LVTNCT07913490
Short-term Application of Lactoferrin Ventilation Tubes
A study testing Ventilation tube insertion in people with Otitis Media With Effusion (OME), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This study aims to evaluate the feasibility and preliminary biocompatibility of a novel lactoferrin-based ventilation tube and its manufacturing process for use in implantable medical materials. Patients with otitis media with effusion who are scheduled to undergo tympanostomy tube placement will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Otitis Media With Effusion (OME)
- What is being tested?
- Ventilation tube insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≤65 years
- Clinically diagnosed with secretory otitis media, with no improvement after conservative treatment (e.g., pharmacotherapy, Eustachian tube inflation) for ≥3 months, and meeting the clinical indications for tympanostomy tube insertion
- Intact tympanic membrane in the affected ear, without old perforation or acute infection
- Provision of informed consent and voluntary participation, with the subject or legal guardian understanding and signing the written informed consent form
Who cannot join
- Ear structural abnormalities: including external auditory canal malformation, middle ear malformation, inner ear malformation, or a history of prior ear surgery that may affect tube placement
- Acute illness or infection within 4 weeks before enrollment: in the acute infection phase such as pneumonia or influenza, or in the recovery phase of acute trauma or surgery
- Presence of craniofacial deformities such as cleft palate
- Allergy history: known allergy to dairy products, lactoferrin, or other protein components, or a history of severe allergic disease
- Coagulation disorders: currently using anticoagulant drugs, or presence of coagulation abnormalities
- Severe systemic diseases: including uncontrolled hypertension, diabetes, heart disease, severe hepatic or renal failure, immunocompromise or immunodeficiency (receiving immunosuppressive therapy, patients with advanced malignancy, patients with AIDS, etc.)
- Special physiological conditions: pregnant or lactating women
- Other circumstances unsuitable for study participation: including psychiatric disorders, cognitive impairment, drug or alcohol dependence, inability to cooperate with follow-up, or other medical or social factors judged by the investigator to make participation in this study inappropriate
About this study
Official title: Safety and Feasibility Evaluation of Lactoferrin Ventilation Tubes in the Short-term Application for Otitis Media With Effusion
This study aims to evaluate the feasibility and preliminary biocompatibility of a novel lactoferrin-based ventilation tube and its manufacturing process for use in implantable medical materials. Patients with otitis media with effusion who are scheduled to undergo tympanostomy tube placement will be enrolled. Before insertion of the standard ventilation tube, the novel lactoferrin-based tube will be temporarily placed at the tympanic membrane incision site. Its handling characteristics and preliminary material properties will be assessed, including successful placement, mechanical strength, and structural integrity during manipulation. Local reactions of the tympanic membrane and surrounding tissues following brief contact will also be observed. The findings will provide preliminary evidence to support further material optimization and subsequent studies. This study is not intended to evaluate the long-term clinical efficacy or safety of the tube as an indwelling tympanostomy device.
- Conditions
- Otitis Media With Effusion (OME)
- Being tested
- Ventilation tube insertion
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation tube insertionDevice
A novel lactoferrin-based ventilation tube will be temporarily placed at the tympanic membrane incision site for approximately 10 minutes before routine tympanostomy tube insertion. Placement feasibility, material integrity, handling characteristics, and local tissue responses will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Device: Ventilation tube insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants at Each Score on the Study-Defined 5-Point Intraoperative Feasibility Scale for Placement and Removal of the Lactoferrin Tympanostomy Tube
For each participant's single study ear, placement and removal will be rated separately on the same study-defined 5-point ordinal scale: 1 (very smooth), first-attempt success without additional manipulation; 2 (basically smooth), first-attempt success with minor adjustment; 3 (partially impeded), success after 2-3 attempts or minor instrument assistance; 4 (difficult), success only after changing instruments, enlarging the tympanic membrane incision, or 4 or more attempts; 5 (failed), unable to complete placement or removal. Lower scores indicate better feasibility. If removal is not attempted because placement failed, removal will be not applicable and will not be imputed.
Measured: From the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.
Number and Percentage of Participants With Any New or Worsened Tympanic Membrane Local Reaction During Temporary Intraoperative Use of the Lactoferrin Tympanostomy Tube
For the single study ear of each participant, the investigator will assess tympanic membrane hyperemia, edema, bleeding, exudation, and any other local reaction after attempted placement, during the temporary dwell period, and immediately after tube removal. A participant will be counted once as having the outcome if at least one reaction is newly observed or worsens from the pre-placement assessment. The number and percentage of participants meeting this definition, with a two-sided 95% exact Clopper-Pearson confidence interval, will be reported using the safety analysis set, defined as all participants in whom placement of the lactoferrin tympanostomy tube is attempted. Each reaction type and severity will also be summarized separately. Multiple reaction types in the same participant will count once in the overall incidence.
Measured: From the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start25 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With Effusion (OME)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Liu, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913490
- Sponsor's protocol ID
- 2026-0492
- Acronym
- ST-LVT
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Evaluation of Lactoferrin Ventilation Tubes in the Short-term Application for Otitis Media With Effusion
- ClinicalTrials.gov ID
- NCT07913490
- Acronym / sponsor ID
- ST-LVT / 2026-0492
- Conditions
- Otitis Media With Effusion (OME)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Nov 2026 (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 aims to evaluate the feasibility and preliminary biocompatibility of a novel lactoferrin-based ventilation tube and its manufacturing process for use in implantable medical materials. Patients with otitis media with effusion who are scheduled to undergo tympanostomy tube placement will be enrolled. Before insertion of the standard ventilation tube, the novel lactoferrin-based tube will be temporarily placed at the tympanic membrane incision site. Its handling characteristics and preliminary material properties will be assessed, including successful placement, mechanical strength, and structural integrity during manipulation. Local reactions of the tympanic membrane and surrounding tissues following brief contact will also be observed. The findings will provide preliminary evidence to support further material optimization and subsequent studies. This study is not intended to evaluate the long-term clinical efficacy or safety of the tube as an indwelling tympanostomy device.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Ventilation tube insertion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≤65 years
- Clinically diagnosed with secretory otitis media, with no improvement after conservative treatment (e.g., pharmacotherapy, Eustachian tube inflation) for ≥3 months, and meeting the clinical indications for tympanostomy tube insertion
- Intact tympanic membrane in the affected ear, without old perforation or acute infection
- Provision of informed consent and voluntary participation, with the subject or legal guardian understanding and signing the written informed consent form
Key exclusion criteria (8 listed)
- Ear structural abnormalities: including external auditory canal malformation, middle ear malformation, inner ear malformation, or a history of prior ear surgery that may affect tube placement
- Acute illness or infection within 4 weeks before enrollment: in the acute infection phase such as pneumonia or influenza, or in the recovery phase of acute trauma or surgery
- Presence of craniofacial deformities such as cleft palate
- Allergy history: known allergy to dairy products, lactoferrin, or other protein components, or a history of severe allergic disease
- Coagulation disorders: currently using anticoagulant drugs, or presence of coagulation abnormalities
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 |
|---|---|---|
| Ventilation tube insertionA novel lactoferrin-based ventilation tube will be temporarily placed at the tympanic membrane incision site for approximately 10 minutes before routine tympanostomy tube insertion. Placement feasibility, material integrity, handling characteristics, and local tissue responses will be assessed. | Device | Experimental group |
Primary outcome
Number and Percentage of Participants at Each Score on the Study-Defined 5-Point Intraoperative Feasibility Scale for Placement and Removal of the Lactoferrin Tympanostomy Tube
Time frame: From the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.
For each participant's single study ear, placement and removal will be rated separately on the same study-defined 5-point ordinal scale: 1 (very smooth), first-attempt success without additional manipulation; 2 (basically smooth), first-attempt success with minor adjustment; 3 (partially impeded), success after 2-3 attempts or minor instrument assistance; 4 (difficult), success only after changing instruments, enlarging the tympanic membrane incision, or 4 or more attempts; 5 (failed), unable to complete placement or removal. Lower scores indicate better feasibility. If removal is not attempted because placement failed, removal will be not applicable and will not be imputed.
Number and Percentage of Participants With Any New or Worsened Tympanic Membrane Local Reaction During Temporary Intraoperative Use of the Lactoferrin Tympanostomy Tube
Time frame: From the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.
For the single study ear of each participant, the investigator will assess tympanic membrane hyperemia, edema, bleeding, exudation, and any other local reaction after attempted placement, during the temporary dwell period, and immediately after tube removal. A participant will be counted once as having the outcome if at least one reaction is newly observed or worsens from the pre-placement assessment. The number and percentage of participants meeting this definition, with a two-sided 95% exact Clopper-Pearson confidence interval, will be reported using the safety analysis set, defined as all participants in whom placement of the lactoferrin tympanostomy tube is attempted. Each reaction type and severity will also be summarized separately. Multiple reaction types in the same participant will count once in the overall incidence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation tube insertion in people with Otitis Media With Effusion (OME), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 and Percentage of Participants at Each Score on the Study-Defined 5-Point Intraoperative Feasibility Scale for Placement and Removal of the Lactoferrin Tympanostomy Tube (time frame: From the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.). The study lists 2 primary outcomes in all. 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 3 Nov 2026.