Clinical Trials Logo
  1. Home
  2. Otitis Media
  3. NCT05741333
  4. Details
NCT05741333 Clinical Trial

In-Office Clinical Study of the Solo+ TTD

Otitis Media Clinical Trial

— VENTY  

Official title:
Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05741333
Other study ID # CSP003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2023
Est. completion date June 2026

Study information
Verified date January 2024
Source AventaMed DAC
Contact Keith Jansen
Phone +353 21 492 8980
Email clinical@aventamed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to <13 years.

Recruitment information / eligibility
Status Recruiting
Enrollment 66
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 6 Months to 13 Years
Eligibility Inclusion Criteria: - Patients aged =6 months to <13 years - Planned tympanostomy tube insertion - Patient is able to commit to the follow-up visits and assessments Exclusion Criteria: - Anatomy that precludes sufficient visualization of the tympanic membrane - Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD - Narrow ear canals - Congenital or craniofacial abnormalities affecting the ear - No baseline audiometry or tympanometry - Familial history of insensitivity to anesthetic components - Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.

Locations
Country Name City State
United States Specialty Physician Associates Bethlehem Pennsylvania
United States South Carolina ENT Columbia South Carolina
United States Advanced ENT & Allergy Louisville Kentucky
United States Sacramento ENT Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
AventaMed DAC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedure Success Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears Intra-operative
Primary Rate of Adverse Events Incidence and nature of device- or procedure-related 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 NCT00044473 - A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat Phase 3