Evaluation of a New Biocompatible Pressure Equalizing Tube

Otitis Media Clinical Trial

Official title:

Evaluation of a New Biocompatible Pressure Equalizing Tube

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01775709
• Other study ID #: 20128774
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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)

Related Conditions & MeSH terms

• Otitis Media

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