RECRUITING

In-Office Clinical Study of the Solo+ TTD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-30

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05741333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 13 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Patients aged ≥6 months to \<13 years * Planned tympanostomy tube insertion * Patient is able to commit to the follow-up visits and assessments	* 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

Inclusion Criteria

Exclusion Criteria

* Patients aged ≥6 months to \<13 years
* Planned tympanostomy tube insertion
* Patient is able to commit to the follow-up visits and assessments

* 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

Contacts and Locations

Study Contact

Keith Jansen

CONTACT

+353 21 492 8980

clinical@aventamed.com

Principal Investigator

Matija Daniel

STUDY_CHAIR

Queen's Medical Center

Study Locations (Sites)

Sacramento ENT

Sacramento, California, 95661

United States

Advanced ENT & Allergy

Louisville, Kentucky, 40220

United States

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017

United States

South Carolina ENT

Columbia, South Carolina, 29203

United States

Collaborators and Investigators

Sponsor: AventaMed DAC

Matija Daniel, STUDY_CHAIR, Queen's Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-30

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-03-30

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Ear Infection
Otitis Media