Clinical Trials Logo
  1. Home
  2. Otitis Media
  3. NCT04148417
  4. Details
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
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 NCT00781521 - Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children Phase 3