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NCT04148417 Clinical Trial

Clinical Study of the Solo+ Tympanostomy Tube Device

Otitis Media Clinical Trial

Official title:
Clinical Study of the Solo+ Tympanostomy Tube Device

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04148417
Other study ID # CSP002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 9, 2021
Est. completion date September 2024

Study information
Verified date January 2024
Source AventaMed DAC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Description:

The study will be a multi-site, prospective, treatment-only study of the Solo+ Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 27
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 6 Months to 15 Years
Eligibility Inclusion Criteria: - Listed for bilateral tympanostomy tube insertion Exclusion Criteria: - Anatomy that precludes sufficient visualisation of both the left and right eardrum - Narrow ear canals - Anatomy that precludes safe access to both the left and right eardrum - Membrane >25% sclerosis - Congenital or craniofacial abnormalities - No available baseline audiometry and tympanometry

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Solo+ Tympanostomy Tube Device
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States Children's National Medical Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
AventaMed DAC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device The number of ears in which the Solo Tympanostomy Tube Device tube is placed Intra-operative
Primary Rate of Adverse Events The number and type of Adverse Events 24 months
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