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The main objective of the observatory study is to evaluate the performance of the Lucie™ medical device for measuring water balance before and after dialysis (water overload, dry weight) in patients with chronic renal failure. We will compare the results and performance of the device with the reference device in nephrology: the BCM®. This comparison is based on bioimpedance. Bioimpedance is an effective technology for monitoring hydration if used regularly, and will give you greater autonomy in your home monitoring. It competes with other technologies that we have found to be less effective. This is what clinical research is seeking to demonstrate: only a clinical study can verify the reliability of this hypothesis. The aim is to help Lucie technology mature so that it can detect early signs of fluid overload, and ultimately prevent complications or hospitalisation.
The process is as follow:
In practical terms, patients are familiar with monitoring their fluid overload using the Fresinus BCM® bathroom scale. They already use it as part of their clinical routine when entering and leaving the dialysis room. This BCM® is used at the start of the dialysis session, before the session begins, by a nurse trained by the manufacturer in its use: he or she knows how to place the electrodes and read the results for status and fluid overload. The nurse also takes patients' usual vital signs (blood pressure, temperature) and notes any incidents during the dialysis session (low blood pressure, cramps, headaches, nausea, etc.) in line with standard practice.
With Lucie™
The goal of this observational study is to evaluate the performance of the Lucie™ medical device for the measurement of pre-dialytic hyperhydration by bioimpedance (water volume in L) in groups of patients with renal failure, compared with the reference device, the BCM. The main question its aimed to answer is
The primary hypothesis will be to determine the degree of agreement between the BMC measure of pre-dialytic hyperhydration and Lucie's water balance (volume (L)).
Participants will do the following tasks :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Arm for PREF-Lucie | Experimental | Interventional, quasi-experimental, multicentre, comparative clinical research study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Treatment | Device | Lucie™ is an innovative medical device for measurement by bio-impedancemetry. It has been developed specifically to meet medical needs in nephrology. The aim of the study is to compare its performance with a reference device validated in nephrology nephrology, the Body Composition Monitor® (BCM) from Fresenius. |
| Measure | Description | Time Frame |
|---|---|---|
| Hydratation parameters | Extra Cellular Water (ECW), Total Body Water (TBW), Intra Cellular Water (ICW) ; the agreement of the variation before and after dialysis with Lucie™ of the hydration parameters (ECW, ICW, ECW/ICW, OH/ECW, TBW) and the actual ultrafiltration of the session displayed on the generator (UF). This measure will help to calculate Bioimpedance measure. | Through study completion (2 months) |
| Concordance of Hydration parameters (%) | Concordance of hydration parameters (OH/ECW (%) (Over Hydration) to Extra Cellular Water), ECW/ICW (%) (Extra Cellular Water to Intra Cellular Water) between the 2 medical devices (Lucie™ and BCM® reference device), as well as sensitivity, specificity, positive predictive value, negative predictive value by Lucie™ medical device. | Through study completion (2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Measures | The agreement between the total weight (kg) measured by the reference device and that measured by Lucie | Through study completion (2 months) |
| Skin/eat Temperature Agreement | The agreement between the skin temperature (°C) measured by Lucie and the ear temperature measured at the patient's bed ; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien Gautier, CEO and Founder | Contact | +336 51 53 61 01 | julien.gautier@home-habilis.com | |
| Ines Hadjidj, System engineer | Contact | +336 49 65 71 26 | ines.hadjidj@home-habilis.com |
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| Label | URL |
|---|---|
| General website of the Sponsor | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D014869 | Water Intoxication |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Through study completion (2 months) |
| Satisfactiory Questionnaire | Patient satisfaction questionnaire to be completed during the dialysis session and at the end of the study by the healthcare professionals who took part. | Through study publication (4 months) |
| Medico-economic Impact | Questionnaire on the medico-economic impact of the use of the Lucie™ device to be completed at the end of the study by the healthcare professionals who took part. | From the end of inclusion to one year after CER publication, assessed to 16 months |
| Organisational Impact | Questionnaire on the organisational impact of the deployment of the Lucie™ system to be completed at the end of the study by the healthcare professionals who took part. | From the end of inclusion to one year after CER publication, assessed to 16 months |
| D014883 | Water-Electrolyte Imbalance |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |