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NOT YET RECRUITING
NCT07913490
NA

Short-term Application of Lactoferrin Ventilation Tubes

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

View on ClinicalTrials.gov

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. 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.

Official title: Safety and Feasibility Evaluation of Lactoferrin Ventilation Tubes in the Short-term Application for Otitis Media With Effusion

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-10-25

Completion Date

2027-01-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

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.