A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System

October 2, 2025 updated by: Karin Hannander, Arjo AB

A 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

Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market (Caylis Pro® LAL System).

A secondary aim is to compare the frequency and amplitude of different pulsation modes with respect to the biomechanical and physiological responses at the participant-support surface interface.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-85
  • Healthy male or female

Exclusion Criteria:

  • Systemic skin disease
  • History of pressure ulcers in the sacrum or heels
  • Diabetes
  • Long term steroid use
  • Inability to maintain lying posture for prolonged periods

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1 study 2 separate session
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.
Device: CLP and pulsation

As an alternative to manual repositioning, advanced air mattress systems have been introduced to periodically relieve support pressures.

A number of measurements have been used to examine the performance of support surfaces. As an example, interface pressure measurements between the individual and the support surface have been extensively used in both lab-based and clinical studies . We are now investigation the functions to reduce pressure in our new Caylis mattress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market.
Time Frame: Day 1 and 2
  • Comfort, support and firmness scores (using a 7 point verbal rating scale )
  • Interface pressure distribution (ForeSitePT, XSensor)
  • Transcutaneous gas levels
  • Microclimate measures between the participant and the support surface using temperature and humidity sensors (Sensiron SH75).
  • Internal Mattress air pressures
Day 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arjo AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

October 2, 2025

First Posted (Estimated)

October 9, 2025

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CaylisPro-MACC-004-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a single centre study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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