A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CLP and pulsation.
- Who it may be relevant to
- Registry conditions: Health Adult Subjects, Pressure Injury Prevention. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.
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.
Interventions
- 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
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07213739 · CaylisPro-MACC-004-2025