Eclevar MedTech / Clinical Investigations / Early Feasibility and Pilot Studies
Validate the procedure, endpoints, operator assumptions and delivery model before committing to the pivotal investigation.
Eclevar designs and delivers medical device early feasibility and pilot investigations across protocol, sites, clinical operations, data and biometrics, with the pivotal decision defined from the start.
An early feasibility or pilot investigation is not a smaller version of the pivotal study. It converts four open assumptions into documented positions before the pivotal protocol is written and the pivotal budget is committed.
Can the procedure be delivered consistently across operators and centers, or does performance still depend on who holds the device?
Are the proposed endpoints measurable, sensitive and operationally feasible at the sites that will run the pivotal?
Where do usability, training and operator learning influence observed performance, and how much of the early signal reflects experience rather than the device?
Are recruitment, visit burden, imaging, follow-up and site requirements realistic at the scale the pivotal will demand?
A pilot investigation is valuable when it changes the assumptions on which the pivotal design will be built.
The decision should be made against the pivotal question, not against a general wish for more data.
If none of the indications on the left apply, we will say so. A study that cannot change a pivotal decision consumes budget, sites and investigator goodwill the pivotal will need.
Five domains typically carry much of the residual uncertainty at this stage. What is left implicit in the pilot tends to return as a protocol amendment in the pivotal.
A small early investigation is not powered to establish efficacy, and rarely able to characterize infrequent safety events. Where a question requires the pivotal to answer it, the report says so rather than presenting a descriptive signal as a conclusion.
In medical devices, the first cases are frequently the least representative. Performance observed early reflects the device together with the experience of the operator and the maturity of the delivery model around it. A pivotal design built on unadjusted early observations inherits that distortion.
Conceptual model: what early observed performance contains
Illustrative only. The axes carry no units, and the figure is not a statistical decomposition of any dataset.
Highest variability.
Handling improves with experience.
Between-case variation narrows.
Values that can inform the pivotal design.
Statistical adjustment cannot reliably remove or separate a learning effect that was not prospectively captured. The controls that make learning interpretable are put in place at design, not at analysis.
A common weakness in early device protocols is that they collect interesting data rather than decision data. The protocol is written backward from the pivotal questions it must close, and each change made during the study passes through a documented pathway.
The purpose of the pilot is not to make the pivotal protocol look inevitable. It is to identify which assumptions are strong enough to carry forward and which still need to change.
An early study is expected to expose impractical steps, ambiguous endpoint definitions, unrealistic visit schedules and unreliable data fields. That is its function. What separates a useful early study from an uncontrolled one is the pathway each observation passes through.
Recorded with its context, not summarized away.
Assessed jointly by the clinical, operational and data leads.
Decision, rationale and owner captured in the study record.
Applied only where justified by the observation.
Effect on participants, data continuity and interpretation recorded.
Changes that require a formal amendment follow the applicable regulatory and ethics pathway in each participating country before implementation.
The value of an early study is realized at one point: the moment the pivotal design is set. Everything the study produces is organized so that it arrives at that decision in usable form.
Pilot to pivotal decision model
The route from residual uncertainty to a pivotal protocol that can be defended in review.
Procedure, endpoints and delivery assumptions not yet validated in clinical use.
Small, tightly governed investigation designed around the pivotal questions.
Procedure, endpoints, operator learning, usability, recruitment, imaging, follow-up, data quality.
What is stable enough to carry forward, and what still needs to change.
Endpoint framework, sample-size assumptions, site and training model, delivery plan.
Each assumption is classified as confirmed, revised or still open, with its evidence and limitations attached.
| Pilot finding | Pivotal decision it informs |
|---|---|
| Endpoint variability | Sample-size assumptions and the choice of primary endpoint |
| Procedure consistency | Training content and operator qualification requirements |
| Recruitment performance | Number of sites and the planned enrollment period |
| Imaging feasibility | Imaging protocol and core-lab strategy |
| Protocol deviations | Protocol simplification and clarification of definitions |
| Operator learning | Investigator qualification criteria and run-in requirements |
| Follow-up burden | Visit schedule and retention strategy |
| Missing data | eCRF design and data-management controls |
Clinical operations, data management and biometrics sit inside one governance structure rather than being handed between vendors.
Database lock is not the end point of an early study. The engagement culminates in a package written for the people who set the pivotal design.
Eclevar is a specialist medical device CRO. Clinical leadership combines practicing physician expertise with first-hand former Notified Body clinical review experience.
Pre-market clinical investigation · Completed
A completed pre-market investigation addressing questions central to pilot-stage decisions: device usability outside a supervised setting, endpoint feasibility, comparative design and multicountry burden.
Crossover investigation architecture
Four evidence domains
Clinical evidence supporting EU MDR clinical evaluation
Evaluate a non-CE-marked investigational catheter against marketed comparators on an objective bladder-emptying endpoint that depends on catheterization technique, on whether the nurse or the participant performs it, and on unsupervised home use.
Investigation CP348, registered as NCT05814211. Multicenter, randomized, open-label crossover design across three European countries. Scale as registered is shown above.
Documented positions on questions often still open when a pivotal design is written: what participants can reliably measure and report on their own, whether the visit and follow-up schedule stayed feasible across three healthcare systems, and where a crossover structure repays the burden it creates. These outputs inform subsequent study design rather than documenting study conduct.
Public registrationClinicalTrials.gov · NCT05814211
This program was a pre-market clinical investigation, not an early feasibility study. The devices are developed and owned by Coloplast A/S; Eclevar contributed to clinical evidence architecture, European delivery and statistical methodology, and did not develop, manufacture or own them. Design, registration and scale details come from the public registration; assessments are described as designed, not as completed. No clinical outcome, comparative claim, superiority conclusion, performance claim or regulatory decision is stated or implied, and no endorsement of Eclevar by Coloplast is implied. Institutions and investigators are withheld.
Early study design is a small number of consequential judgments. The people below make them, and stay with the program through delivery.
Dr. Mark Da Costa
Chief Operating Officer and Head of Cardiovascular · Senior Consultant Surgeon
Dr. Nikhil Khadabadi
Chief Medical Officer, Orthopedics and Spine · Senior Consultant Surgeon
Susanne Höfer
Head of Clinical Operations, DACH region
Sébastien Meier Piantanida
Chief Data Officer
Dawn Heimer, PhD
Strategic Clinical Advisor, United States
Charline Petitdemange, Project Lead, holds day-to-day accountability for study delivery, site management and escalation. Pierre-Marie Boutanquoi, Head of Medical Writing, owns the clinical investigation plan and the early study report that carries the findings into the pivotal decision.
A working session with the clinical, regulatory, operational and data leads who would run the study. It ends with a position on whether an early study is justified and what it must resolve.
Where key design assumptions remain open, we provide a defined budget range and the variables that move it rather than creating false precision.
A small clinical investigation conducted when a device is approaching or entering early clinical use. Its purpose is to reduce uncertainty rather than to demonstrate effectiveness: whether the procedure can be delivered consistently, whether candidate endpoints can be measured reliably, how the device behaves for operators new to it, and whether the operational model holds at site level. The output is a set of documented assumptions for the pivotal design, and a statement of what remains unresolved.
The terms overlap and are used differently across jurisdictions. In general use, an early feasibility study sits closer to first clinical use and often accepts iterative refinement of the device or procedure, while a pilot study assumes a more settled design and concentrates on endpoint and operational feasibility ahead of the pivotal investigation. What matters is the decision the study is built to inform, not the label.
Not automatically, and the two are not legally interchangeable. "Early feasibility study" is in common use in United States device development, where it carries a specific procedural meaning. Under EU MDR 2017/745 the relevant terminology is "clinical investigation", and the requirements follow from the device, its status and the purpose of the study rather than from the label placed on it.
We define the study according to the regulatory pathway, the country strategy and the evidence objective, then use the terminology correct in each jurisdiction involved. Where a program serves both routes, the difference is addressed at design rather than discovered later.
When a specific assumption in the pivotal design is genuinely uncertain and early clinical observation could change it: an unstandardized procedure, endpoints not yet captured operationally, unknown recruitment rates, untested imaging or central review workflows, or sample-size assumptions resting on variability estimates nobody currently has. It is not justified when the pivotal question is already mature, when existing data can close the gap, or when the study would not change the next investigation.
There is no general answer, and any number quoted without reference to the objective should be treated with caution. Sample size follows from what the study must resolve: procedural consistency across operators, endpoint variability or an operational model each imply different numbers, as do the number of sites and of operators per site. Early studies are frequently small, which is why the design must be explicit about which questions it can answer and which it cannot.
At design, because they cannot be reconstructed later from a record that did not capture them: operator qualification and training defined before activation, prior experience documented, procedural metrics such as duration and set-up captured prospectively, and case sequence recorded so early cases can be identified in the analysis.
Where the design and sample support it, case-sequence analysis can describe how performance changes with experience. The limit matters: statistical adjustment cannot reliably separate device-related performance from a learning effect in a small dataset. The objective is to keep the two distinguishable in the record and to state the residual uncertainty.
An early study may include several exploratory endpoints alongside predefined safety and performance endpoints. Whether a primary endpoint is specified depends on the study objective, design and regulatory pathway.
Selection is driven by the pivotal decision the study must inform. Each candidate is assessed for measurement reliability under routine site conditions, sensitivity to the expected clinical effect, timing, the burden it places on sites and participants, and the infrastructure it requires, such as imaging standards or central review.
Yes, and this is often the main reason to run one. Early data can inform endpoint selection, variability estimates that feed sample-size planning, recruitment assumptions per site and per month, investigator qualification criteria, training requirements, visit schedule design, imaging and core-lab strategy, and data-management controls.
The estimates must carry their limitations with them. Variability from a small early sample is itself uncertain, and event rates from a pilot are often not interpretable. Presenting them as settled inputs is a common cause of an underpowered pivotal investigation.
The device and its development stage, intended purpose and target population, preclinical and any existing clinical evidence, the procedure as currently performed, known risks, candidate endpoints, the training concept, the countries under consideration and the expected pivotal pathway.
With that material we produce study architecture, an endpoint shortlist, site requirements and the drivers that determine cost. Where key design assumptions remain open we provide a defined range and the variables that move it.
If the procedure, endpoints, operator requirements or delivery assumptions are still uncertain, define what the early study must resolve before committing the pivotal program.
