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Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

NCT06112054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-03-10

Study results available
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Summary

The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Sensome

    lead INDUSTRY

Principal Investigators

  • Koen Deloose, MD · AZ St Blasius, Dendermonde, Belgium

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2024-08-14
Completion
2024-08-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112054 on ClinicalTrials.gov