Clinical Study of the Solo Tympanostomy Tube Device

The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Study Overview

• Status: Unknown
• Conditions: Otitis Media; Ear Infection
• Intervention / Treatment: Device: Solo TympanostomyTube Device

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olive O'Driscoll; Phone Number: +353 21 492 8980; Email: clinical@aventamed.com

Study Locations

• Italy
  • Trieste, Italy
    • Recruiting
    • IRCCS Burlo-Garofolo
    • Contact: Domenico Leonardo Grasso
• United Kingdom
  • Derby, United Kingdom
    • Recruiting
    • Royal Derby Hospital
  • Nottingham, United Kingdom
    • Completed
    • Queen's Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Solo Tympanostomy Tube Device; The Solo Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure	Device: Solo TympanostomyTube Device; The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of Adverse Events	The number and type of Adverse Events	Intra-operative, 2-6 weeks post-operative

Collaborators and Investigators

• Sponsor: AventaMed DAC

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2018
• Primary Completion (ANTICIPATED): November 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (ACTUAL): October 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: CSP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No