Peripheral Vascular DiseaseSEPARATENCT06112054
Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection
A study testing Clotild Smart Guidewire System (CSGS) in people with Peripheral Vascular Disease, run by Sensome at 1 site in Belgium.
Trial summary
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Clotild Smart Guidewire System (CSGS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Nov 2023to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Subjects with acute and chronic occlusions in the arteries of the lower limbs
- Patients eligible for endovascular interventional procedures
- Written Informed Consent to participate in the study.
Who cannot join
- Target Vessel Aneurysm
- Target vessel diameter <2mm
- Lesions starting at the Common Iliac Artery
- Any subject that is, according to the discretion of the investigator, not eligible for study participation
- Known lactating or confirmation of positive pregnancy test according to site specific standard of care
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).
Read the detailed description
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD)
Previously the CSGS was used in a clinical study in stroke patients (The Clot Out Study) to direct a catheter through blood vessels and to measure electrophysiological parameters in the blood vessels during procedures.
In the current study however, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire System will only be used to perform electrophysiological measurements in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedures.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Clotild Smart Guidewire System (CSGS)
- Keywords
- PAD
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotild Smart Guidewire System (CSGS)Device
In the current study, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire (study device) will only be used to perform electrophysiological measurements (via its sensor) in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedure. During the procedure, the physician acquired measurements at several locations within the lesion to target the various tissues of interest. The physician labeled the data according to tissue type, relying on the patient's symptoms and other available clinical information.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | One arm only - in all eligible study patients, the study device will be used. Receives: Device: Clotild Smart Guidewire System (CSGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal.
The Primary Performance Endpoint is defined as the ability of Clotild® Smart Guidewire System to acquire electrophysiological measurements in the lesion and/or subintimal. This endpoint represents the procedural success rate being defined as the number of patients in whom the CSGS ( Clotild® Smart Guidewire System) obtained at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom CSGS was used.
Measured: During the procedure, up to 95 minutes
Secondary outcomes (1)
The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease
The ability of Clotild® Smart Guidewire System to differentiate various tissues involved in Peripheral Artery Disease such as, but not limited to:
- arterial wall
- subintimal area
- clot (fresh / subacute / organised)
- plaque (soft / hard)
- hyperplasia
Due to limitations in data and label collection, the secondary endpoint could only be assessed by the development of a model performing binary classification distinguishing fresh-clot from every other tissue type.
The non-anomalous impedance measurement are interpreted by a prediction model. This model provides a calibrated probability that a given non-anomalous measurement corresponds to a fresh clot.
To assess alignement with the physician assessment, the model probabilities were compared with the physician assigned labels (fresh clot vs non fresh clot). For each physician's assigned group, the mean calibrated probabilities and its standard deviation are reported.
Measured: During the procedure, up to 95 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start29 Nov 2023
- Primary completion14 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, single group, non comparative study
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koen Deloose, MD, Principal investigator, AZ St Blasius, Dendermonde, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112054
- Sponsor's protocol ID
- SEN-PAD-1
- Acronym
- SEPARATE
- Status last verified
- Feb 2026
- First submitted
- 15 Oct 2023
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection
- ClinicalTrials.gov ID
- NCT06112054
- Acronym / sponsor ID
- SEPARATE / SEN-PAD-1
- Conditions
- Peripheral Vascular Disease
- Keywords
- PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- SensomeIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Posted 10 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).
Detailed description
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD)
Previously the CSGS was used in a clinical study in stroke patients (The Clot Out Study) to direct a catheter through blood vessels and to measure electrophysiological parameters in the blood vessels during procedures.
In the current study however, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire System will only be used to perform electrophysiological measurements in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedures.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, single group, non comparative study
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Clotild Smart Guidewire System (CSGS)One arm only - in all eligible study patients, the study device will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Subjects with acute and chronic occlusions in the arteries of the lower limbs
- Patients eligible for endovascular interventional procedures
- Written Informed Consent to participate in the study.
Key exclusion criteria (5 listed)
- Target Vessel Aneurysm
- Target vessel diameter <2mm
- Lesions starting at the Common Iliac Artery
- Any subject that is, according to the discretion of the investigator, not eligible for study participation
- Known lactating or confirmation of positive pregnancy test according to site specific standard of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clotild Smart Guidewire System (CSGS)In the current study, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire (study device) will only be used to perform electrophysiological measurements (via its sensor) in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedure. During the procedure, the physician acquired measurements at several locations within the lesion to target the various tissues of interest. The physician labeled the data according to tissue type, relying on the patient's symptoms and other available clinical information. | Device | Treatment Arm |
Primary outcome
The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal.
Time frame: During the procedure, up to 95 minutes
The Primary Performance Endpoint is defined as the ability of Clotild® Smart Guidewire System to acquire electrophysiological measurements in the lesion and/or subintimal. This endpoint represents the procedural success rate being defined as the number of patients in whom the CSGS ( Clotild® Smart Guidewire System) obtained at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom CSGS was used.
1 secondary outcome
The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease
Time frame: During the procedure, up to 95 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Deloose, MD principal investigator
AZ St Blasius, Dendermonde, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clotild Smart Guidewire System (CSGS) in people with Peripheral Vascular Disease, run by Sensome at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal. (time frame: During the procedure, up to 95 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.