Evaluation of a New Biocompatible Pressure Equalizing Tube

Not Applicable

Withdrawn

• Conditions: Otitis Media
• Interventions: Device: PE tube with Duckbill Valve

• Registration Number: NCT01775709
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PE tube with Duckbill Valve	PE tube with Duckbill Valve	PE tube with Duckbill Valve

Primary Outcome Measures

Name	Time	Method
Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatment	up to 6 months

Trial Locations

Locations (1)

UCIMC; 🇺🇸 Orange, California, United States