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Caylis Pro® LAL System for Biomechanical and Physiological Responses in Lying Postures

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Study Aim

This study aims to evaluate the effects of the Caylis Pro LAL System on the biomechanical and physiological responses of individuals in lying postures, focusing on prevention.

What is being tested

CLP and pulsation

Device
Who is being recruted

From 18 to 85 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorArjo AB
Study ContactPete Worsley, Prof, Dr, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2025

Actual date on which the first participant was enrolled.

This study is designed to explore how the body responds when lying down for long periods using a new type of mattress system called the Caylis Pro® Low Air Loss (LAL) System. The focus is on understanding how the mattress affects the pressure on the body and blood flow in small blood vessels during these long periods of rest. This research is important as it could lead to better care for people who have to stay in bed for extended times, helping to improve comfort and prevent issues like pressure sores. Participants in the study will lie on the Caylis Pro® mattress system, which provides pulsation therapy to help distribute pressure evenly across the body. Researchers will measure how the mattress affects pressure points and blood flow by comparing different settings on the mattress. The study does not involve taking any medications or undergoing medical procedures, focusing instead on observing the natural responses of the body to the mattress. This research aims to enhance the effectiveness and comfort of mattress systems used in caring for individuals with limited mobility.

Official TitleA Laboratory Trial to Investigate the Biomechanical and Physiological Responses to Prolonged Lying Postures During CLP When Combined With Pulsation Therapy on Caylis Pro® Low Air Loss (LAL) System
NCT07213739
Principal SponsorArjo AB
Study ContactPete Worsley, Prof, Dr, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Age 18-85

Healthy male or female

5 exclusion criteria prevent from participating
Systemic skin disease

History of pressure ulcers in the sacrum or heels

Diabetes

Long term steroid use

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

The healthy volunteers will be placed on a new mattress which has continuous low pressure (CLP and a pulsatio feature) and during that time period different measurements will be taken.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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