Evaluation of a New Biocompatible Pressure Equalizing Tube

NCT ID: NCT01775709

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-09-30

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.

Conditions

Otitis Media

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PE tube with Duckbill Valve

PE tube with Duckbill Valve

Group Type: EXPERIMENTAL

PE tube with Duckbill Valve

Intervention Type: DEVICE

PE tube with Duckbill Valve

Interventions

PE tube with Duckbill Valve

PE tube with Duckbill Valve

Intervention Type: DEVICE

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Hamid Djalilian, M.D.,Associate Professor of Clinical Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elliot Botvinick, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute, UCI

Locations

UCIMC

Orange, California, United States

Countries

United States

Other Identifiers

20128774

Identifier Type: -

Identifier Source: org_study_id