Performance Evaluation of Lucie™ for Hydration of Dialysis Patients

NCT06640270 | Not Yet Recruiting

• 1 other identifier: PERF-LUCIE
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• After removing their shoes and socks, the patient will be invited to step onto the scale;
• Patient will insert a personal card into the card reader and place his right hand loosely on the LucieTM handle, keeping a natural posture;
• The device will take measurements for 45 seconds under the nurse\'s supervision;
• Patient will go down Lucie and will answer a short form;
• The device is cleaned after each use For optimum results, we recommand patients to keep their feet dry and their hands clean (without cream), and we recommend them to remove their jewellery, to keep their smartphones away from the device (to avoid interference), and to wear a minimum of nylon-free clothing, with empty pockets. 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™

Conditions

Diabetes

Keywords

bioimpedance; concordance; hydration match; overhydration; Total Body Water; Extra Cellular Water; Intra Cellular Water; hydration; Over Hydration; predictive value

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (5)

• Weight Measures

  Through study completion (2 months)

• Skin/eat Temperature Agreement

  Through study completion (2 months)

• Satisfactiory Questionnaire

  Through study publication (4 months)

• Medico-economic Impact

  From the end of inclusion to one year after CER publication, assessed to 16 months

• Organisational Impact

  From the end of inclusion to one year after CER publication, assessed to 16 months

Study Arms (1)

Main Arm for PREF-Lucie

EXPERIMENTAL

Interventional, quasi-experimental, multicentre, comparative clinical research study

Device: Diabetes Treatment

Interventions

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.

Main Arm for PREF-Lucie

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age : 18 years min
• Weight minor than 125 kg
• must be able to read
• able to get on and off a bathroom scale, with or without assistance;
• Patient able to stand in balance for 45 seconds with support, alone and barefoot.

You may not qualify if:

• persons with vulnerabilities : pregnant women, nursing mothers, persons deprived of their liberty, adults under legal protection, persons in emergency situations (art. L. 1121-5 to 8 and L.1122-1-2 of the Public Health Code)
• patient with an open wound on the extremities (palms and soles of the feet in contact with the device);
• Patient with an electronic cardiac implant;
• An amputee, with or without a prosthesis;
• Patients with paralysis, even partial paralysis;
• Patients with a 3-month mean natraemia of less than 130 mmol/L;
• Patients fitted with a metal prosthesis;
• Patients with behavioural problems that prevent them from taking part in the study;
• Patient already included in another interventional research study.

Sponsors & Collaborators

• Home Habilis: lead

Related Links

• General website of the Sponsor

MeSH Terms

Conditions

Diabetes Mellitus; Water Intoxication

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Water-Electrolyte Imbalance; Poisoning; Chemically-Induced Disorders

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10