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

Arjo

Status: Not yet enrolling

Conditions: Pressure Injury Prevention; Health Adult Subjects

Treatments: Device: CLP and pulsation

Study type: Interventional

Funder types: Industry

Identifiers

NCT07213739

CaylisPro-MACC-004-2025

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1 study 2 separate session

Other group

Description:

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.

Treatment:

Device: CLP and pulsation