REALITY
Research type
Research Study
Full title
Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator \n
IRAS ID
266138
Contact name
Rebecca Malpass
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 6 months, 30 days
Research summary
The purpose of this research study is to collect long-term, real-world data on the safety and effectiveness of all Abbott, CE marked, commercially available neurostimulators devices, implanted for the treatment of chronic pain. The neurostimulator devices include multiple waveform (tonic or BurstDRTM) stimulators and dorsal root ganglion (DRG) stimulators. The goal is to collect data from participants implanted with these devices, that are used as part of the patients’ standard care. The topics of data collection include pain relief and feelings, daily activities, the neurostimulator settings that your physician has programmed, and how the devices are used. With these data, the plan is to be able to evaluate the quality and performance of Abbott neurostimulator devices and potentially gain a better understanding of chronic pain if possible in relation to the devices. \n\nPatients that will be implanted with an Abbott neurostimulation device (and scheduled to receive permanent neurostimulation system implant with 30 days), as part of their standard care, and meeting the eligibility criteria, will be invited to participate in the study. \n\nThe principal investigator or authorised designee, will screen the patient against the inclusion and exclusion criteria. The PI or designee will discuss the study with those patients that meet the eligibility criteria and follow the informed consent procedure detailed in ISO 14155.\n\nStandard-of-care data will be collected, and pain and QoL-questionnaires will be administered at the baseline-visit and follow-up visits. Additional data will be collected via telephone follow-up (see protocol for details of all data collected).\nParticipants will receive their permanent implant procedure as per standard-of-care. Data will be collected on this. \n\nParticipants will be in the study for 5years in total. Participants will be followed-up in clinic as standard-of-care and additionally receive a telephone follow up every half year for 5years at half-year time points. \n\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0147
Date of REC Opinion
24 Sep 2019
REC opinion
Further Information Favourable Opinion