STAR-LIFE: A POST-MARKET REGISTRY ON MINIJECT (MINI SO627)
Research type
Research Study
Full title
STAR-LIFE: A POST-MARKET REGISTRY ON MINIJECT
IRAS ID
309510
Contact name
K Sheng Lim
Contact email
Sponsor organisation
iSTAR Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The study is observational, multicentric and focused on data collection up to 2 years after surgery in a real-life setting. The device (MINIject version 1.3) and next generations will be implanted permanently, and the delivery system is single use.The registry has 3 main objectives: the collection of real-world evidence on the usability of the device, the patient reported outcomes such as quality of life, and the device safety over a period of 2 years after surgery.
REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0019
Date of REC Opinion
14 Apr 2022
REC opinion
Further Information Favourable Opinion