SAFETY OF SPLENIC NERVE STIMULATION IN PATIENTS WITH RA (GAL1039_V10)

• Research type

  Research Study

• Full title

  A SINGLE ARM PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS USING AN ACTIVE IMPLANTABLE DEVICE

• IRAS ID

  293980

• Contact name

  Shannon Springer

• Contact email

  shannon.x.springer@galvani.bio

• Sponsor organisation

  Galvani Bioelectronics

• Clinicaltrials.gov Identifier

  NCT04955899

• Duration of Study in the UK

  7 years, 1 months, 31 days

• Research summary

  The Galvani Splenic Neuromodulation System for treatment of rheumatoid arthritis (RA) will be assessed under Protocol GAL 1039 in adult subjects with moderate to severely active RA who have experienced prior inadequate response to at least two biologic DMARDs and/or JAK-inhibitors (JAKis). The study will be an open-label single arm study to be conducted in a single center in Glasgow, Scotland. Up to five RA patients will be implanted with the device and following a recovery period receive neurostimulation for 12 weeks. If patients do not adequately respond to stimulation the number of stimulations may be increased, including introducing stimulation during the night.
  The primary objective of this study is to assess safety and tolerability of: (a) Laparoscopic surgical implantation of the Galvani System and (b) splenic neurovascular stimulation using this device, through the 12-week study period. The secondary objectives include to assess effect on biomarkers, evaluate device usability and performance, and assess perception of therapy. Main exploratory objectives include to evaluate the efficacy of splenic neuro vascular bundle stimulation on clinical signs and symptoms and to assess a large set of additional biomarker responses. Upon completion of the of Period 1 (Day 84), participants will en roll in Period 2, the long-term follow-up of which the main purpose is to evaluate the safety, tolerability and efficacy of chronic implantation and active stimulation with the Galvani System.

• REC name

  South East Scotland REC 02

• REC reference

  21/SS/0009

• Date of REC Opinion

  8 Mar 2021

• REC opinion

  Further Information Favourable Opinion