An interventional study of Ventilation tube insertion in Otitis Media With Effusion (OME), sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Basic science
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.
87 studies on the registry are indexed under Otitis Media with Effusion; 16 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 61 interventional studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 97 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
Device: Ventilation tube insertion
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.
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.
Time frame: 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.
Time frame: From the first attempt at tympanostomy tube insertion to 10 minutes after the successful placement of the tube.
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, Zhejiang University, School of Medicine