Evaluation of a New Biocompatible Pressure Equalizing Tube

NCT01775709 | Withdrawn DMC

• 1 other identifier: 20128774
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Otitis Media

Keywords

middler ear infection

Outcome Measures

Primary Outcomes (1)

• Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatment

  up to 6 months

Study Arms (1)

PE tube with Duckbill Valve

EXPERIMENTAL

PE tube with Duckbill Valve

Device: PE tube with Duckbill Valve

Interventions

PE tube with Duckbill Valve DEVICE

PE tube with Duckbill Valve

PE tube with Duckbill Valve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

UCIMC

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Elliot Botvinick, Ph.D.

  Beckman Laser Institute, UCI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hamid Djalilian, M.D.,Associate Professor of Clinical Otolaryngology

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 25, 2013
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)