Health Adult SubjectsNCT07213739
A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System
A study testing CLP and pulsation in people with Health Adult Subjects and Pressure Injury Prevention, run by Arjo AB.
Trial summary
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects, Pressure Injury Prevention
- What is being tested?
- CLP and pulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-85
- Healthy male or female
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.
Read the 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.
- Conditions
- Health Adult Subjects, Pressure Injury Prevention
- Being tested
- CLP and pulsation
- Keywords
- caylis, Arjo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLP and pulsationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 1 study 2 separate session | Other | 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. Receives: Device: CLP and pulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
Measured: Day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- During the test each volunteer will adopt three distinct postures namely supine, lateral lying (pelvis titled to 30°) and cardiac high sitting (head of bed at 45°), while a series of measurements will be performed at the individual-support surface interface.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arjo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Karin Hannander, Arjo AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213739
- Sponsor's protocol ID
- CaylisPro-MACC-004-2025
- Status last verified
- Oct 2025
- First submitted
- 3 Sep 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single centre study
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07213739
- Acronym / sponsor ID
- CaylisPro-MACC-004-2025
- Conditions
- Health Adult Subjects, Pressure Injury Prevention
- Keywords
- caylis, Arjo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Arjo ABIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During the test each volunteer will adopt three distinct postures namely supine, lateral lying (pelvis titled to 30°) and cardiac high sitting (head of bed at 45°), while a series of measurements will be performed at the individual-support surface interface.
| Arm | Type | Receives |
|---|---|---|
| 1 study 2 separate session | Other | Device: CLP and pulsationThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-85
- Healthy male or female
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLP and pulsationAs 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 | Device | 1 study 2 separate session |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No. This is a single centre study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing CLP and pulsation in people with Health Adult Subjects and Pressure Injury Prevention, run by Arjo AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pete Worsley, Prof, Dr, PhD (+46721560709, P.R.Worsley@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.