Research
Clinical Research at PainMedSA - Cercare
Cercare Clinical Research Alliance is an independent, clinical research facility on the edge of Adelaide CBD and is the research arm of PainmedSA. We are at the forefront of evidence-based research with a focus on providing safe, comprehensive, patient-centred care in all areas.
What We Offer
For research volunteers
Our top priority and focus is the safety and wellbeing of our research volunteers. Our expert research team supports volunteers throughout all steps of their clinical trial involvement. From first contact and ensuring involvement in research is suitable for them, coordinating and running visits, information sessions, conversations during studies, and next steps at the completion of the research, we ensure our volunteers have a voice, and are cared for.
For referrers
We appreciate all referrals to PainMedSA for our clinical trials and are more than happy to provide information or support on study availability and criteria. We ensure open communication with the healthcare teams of our volunteers.
For sponsors
We offer a range of clinical research opportunities, for both pre- and post-market studies including world-first research. While Cercare works hand-in-hand with PainMedSA, as a pain-focused clinic with expertise in pain, surgery, technology and devices, Cercare is also open to clinical trials in other areas with broad experience in Phase I (First In Human) through to Phase IV post-market studies. We specialise in international clinical trials and are passionate about supporting home-grown research.
We provide sponsors and clinical research organisations with an experienced, dedicated research team in a purpose-built facility, designed to conduct clinical trials professionally and with an enthusiasm for excellence. We pride ourselves in the collection of high quality data, working to ALCOA principles in all areas including paper source and electronic data capture systems. Our locked, alarmed facilities include examination rooms, monitoring space with wifi, storage space (drugs & devices), centrifuge, dedicated temperature controlled fridge (with back up emergency power) and a freezer (-20 degrees). We offer a multi-disciplinary approach with Medical, Nursing, and Psychology professionals on site, and have links with a number of local hospitals.
Clinical Trial Information
What is a clinical trial?
A clinical trial is a controlled research study that tests innovations, such as devices, drugs or procedures, involving people. In this type of study, volunteers help researchers advance new medical innovations, determining if they are safe, if they work as intended, and how they compare to the options currently used in our health system.
How does a clinical trial work?
Clinical trials are designed to answer specific questions and differ depending on what is being tested, how it is being tested, and the volunteers who can be involved. International laws and rules also ensure all clinical trials are conducted in an ethical and safe manner. Throughout a clinical trial researchers check in with volunteers, and information is collected over time. At the end of a clinical trial the information is reviewed to see if the innovation tested is safe and effective, and, ultimately, is eligible for approval by Australian and international regulatory bodies to be used in routine health care.
Why do we need clinical trials?
Clinical trials collect information about safety and effectiveness of new medical innovations. The information from clinical trials is assessed by regulatory authorities, and if approved, can then be used in our health system to decide on the best options for healthcare to improve patients’ health outcomes and wellbeing.
Types of clinical trials
New medical innovations are tested in four different phases of clinical trials. At Cercare we run clinical trials in phases I, II, III and IV.
Preclinical studies test innovations in a laboratory setting, before testing in people.
Phase I studies test innovations on a small number of people, for the first time. The goal is to measure safety and possible side effects.
Phase II studies build upon the Phase I results and tests innovations in more people. The goal is to assess effectiveness and gain a deeper understanding of possible side effects.
Phase III studies build upon Phase II results and tests innovations in a large number of people. The goal is to prove effectiveness compared to interventions currently available, and if successful, gain regulatory approval to be used in our health system.
Phase IV studies monitor effectiveness and possible side effects after interventions receive regulatory approval to be used in our health system. The goal is to assess the long-term benefits and risks.
Participating in a clinical trial
People can volunteer to be involved in clinical trials to help test new medical innovations, and can ask questions and seek clarification at any stage, it is also possible to opt out at any time, no questions asked.
Your clinical trial journey with Cercare may be similar to the list below, depending on the phase of clinical trial, the design of the clinical trial, and the innovation being tested.
Show your interest
Call us on 08 8340 7733, email us at research@painmedsa.com, or contact us online
Pre-screening - Speak with the Research Team
Our research coordinators will give you a call to discuss the clinical trial and ask preliminary questions to see if it is suitable for you.
Screening visit at PainMedSA
Meet with the study doctor and coordinators to discuss the study further, sign the information sheet and consent form, and go into more detail to assess suitability. This could include medical tests and questionnaires. You may need tests performed elsewhere, for example, X-rays or MRIs, and we will organise these.
Baseline visit at PainMedSA
Meet with the study doctor and coordinators to review further tests and finalise suitability of the clinical trial for you. We will then organise the next steps, which could be receiving a treatment, or booking surgery.
Study visits
Depending on the study, you may have multiple study visits to attend. We organise follow up visits and phone calls to check in with you and collect study information over time. The timing of these visits depends on the design of the clinical trial and your availability.
Final study visit
Meet with the study doctor and coordinators for a final follow up visit, complete the final assessments, and exit from the study. Discussions around your options for after the trial will continue before and after the final visit.
If you are interested in any of the research at Cercare, you can let us know by clicking the ‘enquire about trial’ buttons below. Or, you can contact us by calling 08 8340 7733 and pressing ‘1’ for research or emailing us at research@painmedsa.com.
Clinical Trials
Current Trials
ShiraTronics RELIEV-CM2 STCM02
A Pivotal Study of the ShiraTronics Migraine Therapy System
Volunteers: People with chronic migraine
Vivex VIA-2024-01
ASCEND: VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Volunteers: People with lower back pain due to degenerative disc disease
Presidio fULFill PMH-006
Comparison of Ultra Low Frequency Spinal Cord Stimulation + Conservative Medical Management (CMM) to CMM Alone in the Treatment of Chronic Axial Low Back Pain
Volunteers: People with chronic back pain
Presidio PMH-003
Spinal Cord Stimulation in Patients with Chronic Low Back Pain
Volunteers: People with chronic back pain
Nevro CA2023-1 OUS PPD50
Spinal Cord Stimulation for the Treatment of Chronic Pain
Volunteers: People with a Nevro brand HF10 spinal cord stimulator
Saluda Freshwater CLIN-PCL-007873
Evoke Spinal Cord Stimulation System to treat chronic pain of the trunk and/or limbs
Volunteers: People with a Saluda brand spinal cord stimulator
Boston PRO A7005
Patient Retrospective Outcomes study
Volunteers: People with a Boston brand spinal cord stimulator
Boston Relief A7007
Registry
Volunteers: People with a Boston brand spinal cord stimulator
Mainstay Observational
ReActiv8 Observational Registry
Volunteers: People with a Mainstay brand back muscle stimulator
ShiraTronics RELIEV-CM STCM01
A Pilot Study of the ShiraTronics Migraine Therapy System
Volunteers: People with chronic migraine
Intralink Spine ILS-CIP-002
Buffered GEnipin Microinvasive Device for Treatment of Low Back Pain from Degenerative Disc Disease - CE Marking Safety and Efficacy Study
Past Trials
Abbott Gemini
CRD_1030 Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System
Chronic Low Back Pain Survey in Australia
Eudaemon GEL-001
A Randomised Open Label Experience and Preference Study of the Geldom Condom Material Versus a Latex Comparator Condom
Eudaemon GEL-003
A Randomised Open Label Two-Way Crossover Evaluation of the Preference, Performance and Acceptability of an Investigational Hydrogel Male Condom (GELDOM) Compared to a Commercial Latex Condome During Vaginal Intercourse
Mainstay Reactiv8-A
Investigation of the ReActive8 Implantable Stimulation System for Chronic Low Back Pain
Mainstay Reactiv8-B
ReActive8 Implantable Stimulation System for Chronic Low Back Pain
Nalu Nalu01-2018-AUS
Spinal Cord Stimulation in the treatment of Chronic, Intractable Pain using the Nalu Neurostimulation System
Pfizer C4951004
A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Pfizer C4951012
A Phase 4, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults with a History of Inadequate Response to Oral Preventative Medications
Presidio PMH-005
Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of an Ultra-Low Frequency Spinal Cord Stimulator in Subjects with Painful Diabetic Neuropathy
Presidio PMH002
A Randomised, Controlled, Multi-Center, Non-inferiority Trial to Evaluate the Safety and Efficacy of Ultra-Low Frequency Spinal Cord Stimulation Compared to Traditional Spinal Cord Stimulation in Subjects with Chronic Back Pain with/without
SpineThera SALIENT
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase I/II, First-in-Human Study to Assess the Safety and Efficacy of Two Doses of SX600 Administered by Lumbosacral Transforaminal Epidural Injection in Patients With Radicular Pain Secondary to Lumbar Intervertebral Disc Herniation
