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Spinal cord stimulation · Class III implantable devices · Regulation (EU) 2017/745Design and run spinal cord stimulation clinical investigations in Europe with integrated protocol strategy, implanting-center feasibility, ISO 14155 clinical operations, monitoring, electronic data capture, biostatistics and long-term evidence generation.
From trial stimulation criteria and responder endpoints through permanent implantation, revision and explant capture, long-term follow-up and post-market clinical follow-up.
Five stages: trial stimulation, conversion decision, permanent implantation, programmed therapy over time, long-term outcome and device events.
Data captured across every stage: therapy parameters, parameter changes, concomitant therapy, device deficiencies, revision and explant.
Many SCS investigations span distinct trial-stimulation, implantation and long-term follow-up phases that have to remain connected through the protocol and the dataset. Four recurring design decisions can materially affect the interpretability of the study, and all four are protocol decisions.
A trial stimulation period is a screening step with a decision attached. Where a protocol includes one, it should state what is assessed, over what period and by whom, and what result supports progression to permanent implantation. It should also state what happens to participants who do not progress: whether they are followed, and which analysis population holds them. Left to site practice, the resulting study population becomes difficult to describe.
The responder definition can be central to the clinical evidence argument and needs to be prospectively justified for the indication, the instrument and the follow-up point. A threshold well supported in one chronic pain population does not transfer automatically to another indication or another instrument. The definition should be fixed before enrollment and carried consistently into the statistical analysis plan.
Lead migration, lead fracture, connector and extension issues, infection, battery depletion, elective revision, reoperation and explant sit on different clinical timelines, and reporting conventions differ between centers. Where coding is inconsistent, a neurostimulation dataset can become difficult to interrogate. The event taxonomy should exist before first patient in and should reconcile with the manufacturer's vigilance and complaint-handling terminology.
Analgesic use, dose changes, physiotherapy, injections and further surgery can all move the outcome the study is measuring. Captured only as free text at the final visit, concomitant therapy can materially limit interpretation of the treatment effect. Capture windows, dose recording, medication categories and the analytical handling of these events are protocol and data management decisions taken together.
Eclevar runs as one delivery team the workstreams that are often split across several suppliers. Where a workstream is a service in its own right, the detail sits on its own page.
Objectives, population and eligibility, the trial stimulation phase and its criteria, the implantation pathway, the visit schedule and the endpoint set.
Responder definitions and their effect on sample size, the treatment effect the study is estimating, how intercurrent events such as explant are handled, and a pre-specified missing data and sensitivity strategy.
Protocol-relevant patient and implant volume, investigator experience with the system class, programming arrangements, the revision and explant pathway, and long-term follow-up capacity.
Eclevar leads and coordinates regulatory and ethics start-up, using in-house delivery or qualified local support according to the country, authority and submission pathway, with site contracting, activation tracking and investigator training. Study start-up services.
On-site, remote and centralized review combined according to the study's risk profile, concentrating on the implantation record and primary endpoint integrity. Clinical trial monitoring services.
A database designed around the therapy rather than the visit schedule, with protocol-specific edit checks, ongoing data review and a controlled lock. Clinical data management.
Adverse event and serious adverse event handling, device deficiencies and adverse device effects as applicable under ISO 14155, safety reconciliation with the manufacturer's vigilance records, and CRO medical review of the safety dataset. This is the CRO safety function. It sits alongside the indication-specific clinical judgment of the investigator team and, where required by the program, of appropriately qualified independent specialists. Neither substitutes for the other.
Study outputs feed the clinical investigation report, the clinical evaluation and the PMCF plan.
Depending on contracted scope, an SCS engagement produces some or all of the following. Not every deliverable applies to every program.
Recruitment in spinal cord stimulation depends on access to the implanting pathway rather than on the reputation of the institution. Eclevar assesses centers against the whole pathway, not against a single number.
Recent protocol-relevant patient volume over an assessment period defined for the study, in the population your inclusion criteria describe.
Implants of the system class under study, over the same defined period.
Who implants, how often, and how much of that person's time is available to the study alongside routine care.
Who performs programming, who is delegated to do so, whether those responsibilities are protocol-compliant, whether parameters are reliably documented, and whether the study team can reconstruct treatment exposure from the record.
Whether revision and explant are performed on site or referred elsewhere, and how events are captured either way.
Research staff, source documentation practice, delegation, and prior experience with implantable device investigations.
What other studies are open at the center, the competing clinical workload, and the research capacity available for the proposed program.
Whether the center can hold participants across the follow-up horizon the evidence argument requires.
Eclevar supports multicountry European SCS studies through a combination of in-house clinical operations and qualified local coverage where appropriate, with central program governance, data, biometrics and medical writing. Regulatory and ethics start-up is led and coordinated by Eclevar according to the country, the authority and the applicable submission pathway. Country-level coverage is confirmed during feasibility and site selection.
The questions Eclevar works through with the sponsor, the investigators and the statistician before the protocol is fixed.
Thresholds, instruments and analysis populations are described here in general terms. No responder definition applies automatically to every SCS indication or program. Study-specific wording is set with the sponsor and reviewed by the investigators appointed for the program before it enters a protocol.
Sample size, the statistical analysis plan and the final analysis are described in full on our medical device biostatistics page.
A visit-driven database records that a programming visit happened. A fit-for-purpose SCS database should capture what was delivered, when it changed, why, and what the participant reported afterwards. That distinction can materially affect whether the analysis can reconstruct and describe the therapy that was actually delivered.
Where the programmer or device provides an electronic configuration export and the protocol requires its use, that export is reconciled against the study record rather than transcribed by hand. Not every SCS platform exposes the same parameters or the same export structure, so the data model is specified per system. Electronic system validation scope is stated per engagement. See also clinical data management and EDC for device studies.
The verification strategy is defined according to the study's risk profile, the critical data and processes, the protocol requirements and the Monitoring Plan. In an SCS study it concentrates on consent and eligibility, trial stimulation documentation, the implantation record and the conversion decision, parameter changes, device accountability, revision and explant reporting, and primary endpoint data. See our clinical trial monitoring services, and on-site and remote monitoring for how visits are run.
A spinal cord stimulator stays in the patient for years. Depending on the system and the intended clinical claim, long-term questions may include sustained clinical benefit, battery or recharge considerations, replacement, revision, explant and cumulative reoperation. These are separate questions from the one a pivotal study answers, and each needs a structure that survives site turnover and patient attrition.
Where applicable, the PMCF plan and PMCF evaluation report can be structured in line with Regulation (EU) 2017/745 Annex XIV Part B and the MDCG 2020-7 and MDCG 2020-8 guidance templates. The PMCF strategy should be designed to support evaluation of safety and performance across the expected device lifetime, using appropriately justified methods, follow-up periods and complementary clinical data sources: long-term clinical follow-up, PMCF investigations, registries, real-world evidence and other appropriate clinical data. See also post-market clinical follow-up and the clinical evaluation report.
Eclevar leads clinical evidence strategy, European study delivery, biometrics, safety reporting and CRO medical review, and regulatory integration. Indication-specific clinical judgment is provided through the investigator team and, where required by the program, appropriately qualified independent specialists. The two are separate functions and neither substitutes for the other.
Chief Operating Officer
Class III clinical-evidence strategy and dossier architecture, informed by first-hand Notified Body review experience.
Chief Medical Officer, Orthopedics and Spine, NHS surgeon
Class III implantable methodology and spinal surgical pathway design, including the revision and explant workflows an SCS protocol has to specify.
Chief Clinical Operations and Strategy Officer
European study execution, site activation, monitoring and cross-functional program governance.
Chief Data Officer, Head of Biometry
EDC architecture for therapy-parameter data, database governance, biostatistics and the analysis-ready dataset.
Clinical Operations Director
European clinical-study delivery, site management and operational coordination.
Head of Medical Writing
Clinical investigation reports, clinical evaluation reports, PMCF evaluation reports and clinical-evidence reporting.
Eclevar's relevant team experience in this field is in Class III implantable device methodology, spinal surgical pathway design and neurostimulation evidence strategy. It is not presented as stimulation programming experience.
Former positions are stated for biographical context only. Eclevar MedTech is an independent contract research organization. It is not affiliated with, accredited by or endorsed by any Notified Body. Notified Bodies issue certificates; individual reviewers assess technical documentation and clinical evidence. Meet the leadership team.
Implant pathway design, revision and explant workflow specification, and the endpoint architecture a Class III implantable submission has to defend, applied by a practicing spine surgeon and by evidence strategy informed by Notified Body review experience.
A randomized post-market clinical follow-up program of 160 participants across 14 clinical sites in several European countries, running two cohorts against the same protocol architecture, with start-up, activation and central biometrics coordinated by Eclevar. Delivered in another therapeutic area and cited for delivery capability rather than for indication experience.
Clinical-evidence considerations relevant to Class III implantable device submissions · dataset requirements behind a contested endpoint definition · structured capture of therapy parameters and device configuration · PMCF architecture designed to feed the clinical evaluation it supports · multicountry activation, monitoring and central biometrics.
Each entry describes the documented scope of that engagement. Client success stories.
Eclevar integrates clinical evidence, data, regulatory and quality expertise for medical devices.
With implant pathway design specified by a practicing spine surgeon.
So the protocol, the database, the analysis and the report are built against each other rather than handed between suppliers.
Combining in-house clinical operations with qualified local coverage where appropriate, under central program governance.
Platinum Award, xShare and the European CRO Federation, "EHDS and Clinical Research" Open Call. Awarded to Eclevar MedTech and its Milo Health platform, EUCROF 2026, Amsterdam, 2 February 2026, Horizon Europe Grant Agreement No. 101136734. A clinical data and research platform award, not a neuromodulation award.
A clinical investigation plan that resolves the trial stimulation and conversion criteria, a statistical analysis plan built around a justified responder definition, implanting-center feasibility assessed against the pathway rather than a procedure count, regulatory and ethics start-up, risk-proportionate monitoring, an EDC that holds therapy parameters and device events as structured data, and the medical writing that follows.
Starting from the indication rather than the center's reputation: recent protocol-relevant patient and implant volume over a defined assessment period, whether the multidisciplinary team the protocol assumes exists with capacity, how programming is performed and documented, and whether revision and explant are performed on site or referred.
Before enrollment, and justified for the specific indication. The threshold, the instrument and the assessment timepoint should be justified using the relevant clinical evidence, literature, clinical rationale and intended clinical claim, with the effect of each candidate definition on sample size set out so the sponsor and the investigators choose on the record.
As distinct phases with a documented decision between them: what is assessed, over what period and by whom, what result supports progression, and which analysis population holds those who do not progress.
Against a prospective event taxonomy covering revision, migration, explant and device deficiencies, defined before first patient in, so terminology remains consistent across the clinical database, complaint handling and vigilance workflows.
A PMCF investigation may be used to address specific post-market clinical questions identified through the clinical evaluation, post-market surveillance and risk-management process. Where an SCS clinical investigation is intended to contribute to that evidence, its population, endpoints, follow-up and data architecture should be planned against those questions from the design stage.
In structured fields rather than free text: the device-specific parameters applicable to the system under investigation, the program identifier, and the date and reason for each change. An electronic configuration export, where the protocol requires its use, is reconciled against the study record.
Yes. Eclevar integrates biostatistics and clinical data management within the program governance model, including sample-size strategy, SAP development, database design, data review, database lock and final analysis according to contracted scope.
Yes. Eclevar supports multicountry European SCS studies through a combination of in-house clinical operations and qualified local coverage where appropriate, with central program governance, data, biometrics and medical writing. Country-level coverage is confirmed during feasibility.
The results and clinical data generated by the investigation can contribute to the clinical evaluation and are documented through the Clinical Investigation Report. The updated clinical evaluation identifies the questions that remain open, which can inform the subsequent PMCF strategy.
Bring us the device, the intended indication, the current evidence and the target markets. We will review the study pathway, the endpoint strategy, European site feasibility and the evidence gaps with your team.
Confidentiality and NDA arrangements can be agreed before detailed program materials are reviewed.
For sponsors with a synopsis or protocol already drafted.
For sponsors choosing countries and implanting centers.
For sponsors requiring protocol through CIR and long-term evidence planning.
