Clinical Study of the Solo Tympanostomy Tube Device

• Sponsor: AventaMed DAC (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03722160
• Collaborator: (none)
• Enrollment: 27
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 13.6
• Patients Per Site: 9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ear Infection; Otitis Media	Device: Solo TympanostomyTube Device	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study of the Solo Tympanostomy Tube Device
• Actual Study Start Date: Sep 13, 2018
• Anticipated Primary Completion Date: Nov 1, 2019
• Anticipated Study Completion Date: Nov 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device [Intra-operative]

   The number of ears in which the Solo Tympanostomy Tube Device tube is placed

2. Rate of Adverse Events [Intra-operative, 2-6 weeks post-operative]

   The number and type of Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Burlo-Garofolo	Trieste		Italy
2	Royal Derby Hospital	Derby		United Kingdom
3	Queen's Medical Centre	Nottingham		United Kingdom

Sponsors and Collaborators

• AventaMed DAC

Investigators

• Study Chair: Matija Daniel, Queen's Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AventaMed DAC
• ClinicalTrials.gov Identifier: NCT03722160
• Other Study ID Numbers: CSP001
• First Posted: Oct 26, 2018
• Last Update Posted: Oct 28, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Otitis; Otitis Media

Study Results

No Results Posted as of Oct 28, 2019