Clinical Study of Solo Tympanostomy Tube Device v1.0
Research type
Research Study
Full title
Post-Market Approval Study of the Solo Tympanostomy Tube Device
IRAS ID
208475
Contact name
Matija Daniel
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Middle ear fluid is the leading cause of paediatric hearing impairment, the recommended treatment of which is tympanostomy tube (grommet) insertion. Several pieces of instrumentation are necessary for tube insertion, including a knife for eardrum incision and forceps and probes to transfer and place the grommet. This multi-instrument procedure requires stillness for up to 20 minutes, necessitating the use of general anaesthesia in children. This makes grommet 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. Any procedure to streamline and speed-up current clinical practice, and reduce the need for general anaesthesia would, therefore, be welcomed.
With this aim, the Solo Tympanostomy Tube Device (TTD; AventaMed) was developed, consolidating all surgical instruments into one hand-held device, allowing clinicians to create an eardrum incision and insert a grommet quickly without general anaesthesia. To use, the device is placed into the ear, the eardrum pierced with the tip and a button pushed to deploy the pre-loaded grommet. The device is approved for the European market, however, this study represents its first clinical use. This study is, therefore, a post-market approval study of a CE-marked device in which feedback on first clinical use is sought.
In the proposed study each investigator will first complete bilateral grommet placement in 4 ears (2 patients) using the Solo TTD and general anaesthesia. Thereafter, patients will be enrolled into the study cohort, consisting of 40 ears (20 patients) treated with the Solo TTD and moderate sedation. Local/topical anaesthetic may also be applied to the membrane.
The primary outcome is intra-operative device success, defined as successful grommet placement using the Solo TTD. Secondary outcome measures relate to clinical outcomes, device/procedure satisfaction, device procedure length, and serious adverse events.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0391
Date of REC Opinion
3 Oct 2016
REC opinion
Favourable Opinion