In-Office Clinical Study of the Solo+ TTD

Launched by AVENTAMED DAC · Feb 14, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the Solo+ Tympanostomy Tube Device (Solo+ TTD), which is designed to help place small tubes in the ears of children who have frequent ear infections, also known as otitis media. The goal is to see how safe and effective this device is for young patients who need a procedure to insert these tubes. The study is currently recruiting participants, specifically children aged 6 months to 13 years who are scheduled to have a tympanostomy, which is the procedure to put in these tubes.

To participate, children must be able to attend follow-up visits after the procedure. However, there are some reasons a child might not be eligible, such as if they have narrow ear canals or certain ear anatomy that makes it hard to see or safely reach the eardrum. During the trial, participants will undergo the tympanostomy procedure in a doctor's office using the Solo+ device. Parents can expect to receive information about the process, and the child's progress will be monitored closely. This trial aims to provide valuable insights into improving ear health for children who suffer from recurring ear infections.

Gender

ALL

Eligibility criteria

• 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