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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Recruitment Status : Withdrawn (no participants enrolled)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

Tracking Information
First Submitted Date  ICMJE January 14, 2013
First Posted Date  ICMJE January 25, 2013
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2013)
Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatment [ Time Frame: up to 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Pressure Equalizing Tube [ Time Frame: up to 6 months ]
Pressure Equalizing Tube
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a New Biocompatible Pressure Equalizing Tube
Official Title  ICMJE Evaluation of a New Biocompatible Pressure Equalizing Tube
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Otitis Media
Intervention  ICMJE Device: PE tube with Duckbill Valve
PE tube with Duckbill Valve
Study Arms  ICMJE Experimental: PE tube with Duckbill Valve
PE tube with Duckbill Valve
Intervention: Device: PE tube with Duckbill Valve
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 22, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2013)
110
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01775709
Other Study ID Numbers  ICMJE NIH/LAMMP-2012-8774
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beckman Laser Institute and Medical Center, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Beckman Laser Institute University of California Irvine
Investigators  ICMJE
Principal Investigator: Elliot Botvinick, Ph.D. Beckman Laser Institute, UCI
PRS Account University of California, Irvine
Verification Date February 2017

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