Evaluation of a New Biocompatible Pressure Equalizing Tube

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	Complete list of historical versions of study NCT01775709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Not Applicable
Study Design ICMJE	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	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	September 2014
Actual Primary Completion Date	September 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male/ female at all age- newborn to adult.; Non- pregnant woman.; Diagnose of middle ear infection and plan for surgery procedure Exclusion Criteria: 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)
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	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	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