Study of the Hummingbird TTS™ Tympanostomy Tube System

Preceptis Medical

Status: Completed

Conditions: Otitis Media

Treatments: Device: Hummingbird Tympanostomy Tube System

Study type: Observational

Funder types: Industry

Identifiers

NCT03503591

Preceptis PMS

Details and patient eligibility

About

The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.

Full description

The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.

Enrollment: 109 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 6 months through 5 years of age
• Candidates for ventilation tube placement
• H-TTS used under moderate sedation and local anesthetic

Trial design