Clinical Study of Solo Advance TTD v1.0
Research type
Research Study
Full title
Clinical Study of the Solo Advance Tympanostomy Tube Device
IRAS ID
249276
Contact name
Matija Daniel
Contact email
Sponsor organisation
AventaMed DAC
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Tympanostomy tubes (grommets, ventilation tubes) are small, hollow cylinders, usually made of plastic or metal that are surgically inserted into the tympanic membrane (eardrum) to ventilate the middle ear. The commonest indications for tube insertion are Otitis Media with Effusion (glue ear) and Acute Otitis Media (ear infection) with 1 in every 15 children requiring tubes at some stage.
Standard tube insertion is a multi-instrument procedure requiring stillness for up to 20 minutes which in children, necessitates the use of general anaesthesia. This makes tube insertion the most performed childhood surgery with general anaesthesia. Concerns have been raised about the use of general anaesthesia and its potential neurotoxic effects in young patients. Furthermore, the need for an operating theatre makes tube insertion a costly procedure with long waiting lists. Any strategy to streamline tube insertion and move it away from the operating theatre into an office/clinic setting would, therefore, be welcome.
With this aim, the Solo Advance Tympanostomy Tube Device (TTD) was developed by AventaMed DAC (Ireland), consolidating all surgical instruments into one hand-held device, allowing clinicians to create an eardrum incision and insert a tube quickly without the need for general anaesthesia. The device is approved for the European market, however, this study represents its first clinical use. This study is, therefore, a study of a CE-marked device in which feedback on first clinical use is sought.
In the proposed study it is estimated up to 30 paediatric patients requiring bilateral tubes (60 ears) will be treated using the Solo Advance TTD under general anaesthesia in the operating theatre.
The primary outcome is intra-operative device success, defined as placement of the Solo Advance TTD tube. Secondary outcome measures relate to serious adverse events and the rate of additional instrument use for placement of tubes.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0174
Date of REC Opinion
29 Aug 2018
REC opinion
Further Information Favourable Opinion