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Withdrawn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
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Tracking Information | ||||
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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 |
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 |
Pressure Equalizing Tube [ Time Frame: up to 6 months ] Pressure Equalizing Tube
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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). |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Otitis Media | |||
Intervention ICMJE | Device: PE tube with Duckbill Valve
PE tube with Duckbill Valve |
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Study Arms | Experimental: PE tube with Duckbill Valve
PE tube with Duckbill Valve
Intervention: Device: PE tube with Duckbill Valve |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
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 |
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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 |