Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01775709
Other study ID # 20128774
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2012
Est. completion date September 2014

Study information

Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PE tube with Duckbill Valve
PE tube with Duckbill Valve

Locations

Country Name City State
United States UCIMC Orange California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatment up to 6 months
See also
  Status Clinical Trial Phase
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02452164 - Family MobilePhone Otoscopy in Diagnostics of Otitis Media N/A
Completed NCT01199016 - Effect of Prevnar 13 on Ear Infections in Children Phase 4
Terminated NCT00778063 - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients N/A
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Recruiting NCT03722160 - Clinical Study of the Solo Tympanostomy Tube Device N/A
Recruiting NCT04447521 - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Completed NCT02600559 - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes Phase 3
Completed NCT01444391 - inVENT-visIOn Study N/A
Enrolling by invitation NCT01437436 - The Effect of Obesity on Ventilation Tube Insertion N/A
Completed NCT01003210 - Homeopathic Ear Drops for Otitis Media Study N/A
Completed NCT00768534 - Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media N/A
Recruiting NCT00393159 - The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children Phase 4
Completed NCT00617682 - Maternal Immunization To Prevent Infant Otitis Media Phase 1/Phase 2
Withdrawn NCT00956748 - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Phase 4
Withdrawn NCT01908764 - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery Phase 1
Recruiting NCT01619462 - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children Phase 3
Completed NCT02616458 - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population N/A
Completed NCT00051753 - Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media Phase 3