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Evaluation of a New Biocompatible Pressure Equalizing Tube

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ClinicalTrials.gov Identifier: NCT01775709
Recruitment Status : Withdrawn (no participants enrolled)
First Posted : January 25, 2013
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

January 14, 2013
January 25, 2013
February 10, 2017
July 2012
September 2014   (Final data collection date for primary outcome measure)
Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatment [ Time Frame: up to 6 months ]
Pressure Equalizing Tube [ Time Frame: up to 6 months ]
Pressure Equalizing Tube
Complete list of historical versions of study NCT01775709 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of a New Biocompatible Pressure Equalizing Tube
Evaluation of a New Biocompatible Pressure Equalizing Tube

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).

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Otitis Media
Device: PE tube with Duckbill Valve
PE tube with Duckbill Valve
Experimental: PE tube with Duckbill Valve
PE tube with Duckbill Valve
Intervention: Device: PE tube with Duckbill Valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
110
September 2014
September 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01775709
NIH/LAMMP-2012-8774
Yes
Not Provided
Not Provided
Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
Beckman Laser Institute University of California Irvine
Principal Investigator: Elliot Botvinick, Ph.D. Beckman Laser Institute, UCI
University of California, Irvine
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP