Skip to content

Evaluation of a New Biocompatible Pressure Equalizing Tube

Evaluation of a New Biocompatible Pressure Equalizing Tube

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01775709
Enrollment
0
Registered
2013-01-25
Start date
2012-07-31
Completion date
2014-09-30
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

middler ear infection

Brief summary

Otitis media is the most common illness in children and 5% to 10% of their symptom cause by fluids in their middle ear . The OME can cause hearing loss included poor development of speech and poor communication. The surgical procedure is considered simple and relatively safe, but several complications may occur after Pressure Equalizing tube insertion. The most prevalent complications are otorrhea, biofilm and formation of retraction pockets. Otorrhea occurs in 30% to 83% of children with tube and is mainly due bacterial contamination of the middle ear either from external ear canal or impaired Eustachian tube. Swimming can facilitate the entry of bacteria into the middle ear from the ear canal through the PE tubes, and this assumption is reinforced by the statistically significant association between the rate of otorrhea and the non-utilization of ear plugs in children who swim (from 47% in children who used ear plugs to 56% in those who did not).

Detailed description

The researcher at Beckman Laser Institute, University of California, Irvine, develops new medical tool device call biocompatible Pressure Equalizing tube which can stop air passage and pressure equalization instantly, and can prevents water into the middle ear cavity. evaluate and compare the efficacy of a biocompatible Pressure Equalizing tube that enables air passage and pressure equalization almost instantly, while prevents the entrance of fluids, specially water, into the middle ear cavity. The biocompatible Pressure Equalizing tube can reduce the rate of postoperative otorrhea,air passage between outside and middle ear cavity,prevents formation of retraction pockets in TM and swimming with lower risk of otorrhea.

Interventions

DEVICEPE tube with Duckbill Valve

PE tube with Duckbill Valve

Sponsors

Beckman Laser Institute University of California Irvine
CollaboratorOTHER
University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Male/ female at all age- newborn to adult. 2. Non- pregnant woman. 3. Diagnose of middle ear infection and plan for surgery procedure

Exclusion criteria

1. Pregnant woman 2. Incompetent adults (i.e. individuals with cognitive impairment) 3. Presence of immunodeficiency; cystic fibrosis; sickle cell disease; 4. Another major systemic disease 5. Congenital malformation of the external, middle, or inner ear 6. Sensorineural hearing loss; otoneurologic disease 7. History of prior ear surgery such as tympanoplasty, tympanomastoidectomy, or mastoidectomy; cholesteatoma; chronic mastoiditis; intratemporal or intracranial suppurative complications of otitis media 8. Use of ototoxic medication (except topical use)

Design outcomes

Primary

MeasureTime frame
Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatmentup to 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026