Verification of the cooling effect of a prototype cryotherapy device with deep body temperature control function around the knee joint in healthy individuals

JRCT ID: jRCT1052240180

Registered date:08/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: able-bodied person
• Date of first enrollment: 23/10/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Use of a cooling device with a knee depth thermometer on able-bodied person to check operability

Outcome(s)

• Primary Outcome: Percentage of additional parts that worked properly
• Secondary Outcome: Comparison of temperatures measured with additional components and Coartemp CM-210

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.At least 18 years of age at the time of registration.
2.Those who have obtained free and voluntary written consent from the individual.

Exclude criteria

1.Those who are judged by the investigator to have some symptoms or abnormal findings in the knee joint.
2.Previous history of traumatic injury
3.Patients with any of the following conditions that are contraindicated or prohibited by the CE4000II icing system
Raynaud's syndrome,Other vasospastic diseases
Hypersensitivity to cold
Poor local blood circulation
Extremities are insensate
4.Those with wounds at the site of the cooling pad or surface temperature application
5.Persons who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Yasuda Tadashi