Research on the safety of new heating device

A single-blind, placebo-controlled study examining the safety of a new heating device using carbon dioxide gas

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052240041

Enrollment

Registered

2024-05-21

Start date

2024-05-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy people

Interventions

Four series of experiments will be conducted on one subject: carbon dioxide gas (room temperature/warming) and placebo (room temperature/warming). The evaluation is conducted for a total of 60 minutes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy individuals aged 20 to 50 at the time of consent (those who do not have a specific chronic disease (however, hypertension and diabetes controlled by oral medication are acceptable.) and who do not have any problems with daily activities. ) 2. Gender doesn't matter 3. Persons who have given their own voluntary written consent to participate in this clinical research

Exclusion criteria

Exclusion criteria: 1. People who are deemed unsuitable by the person in charge of this clinical research 2. People with skin diseases on both upper limbs 3. People with a history of serious cardiovascular disease, cerebrovascular disease, or respiratory disease 4. Pregnant women, people who may be pregnant, or people who are breastfeeding 5. Persons who have participated in another clinical trial within the past 4 months

Design outcomes

Primary

Measure	Time frame
Measure surface skin temperature every 5 minutes from the start of device use until 40 minutes after device use Assessment of pain, itching, and sensory abnormality and surface skin temperature of the upper extremity on the side where gas is administered before and immediately after the use of the device (20 minutes) and at the end of the follow-up observation (40 minutes) Blood pressure, pulse rate, body temperature, SpO2, pCO2 every 5 minutes from the start of device use until 40 minutes after device use Appearance and severity of nausea, vomiting, fatigue, cough, dyspnea, and palpitations from the start of device use to 40 minutes after device use (CTCAE v5.0)	—

Measure

Time frame

Measure surface skin temperature every 5 minutes from the start of device use until 40 minutes after device use Assessment of pain, itching, and sensory abnormality and surface skin temperature of the upper extremity on the side where gas is administered before and immediately after the use of the device (20 minutes) and at the end of the follow-up observation (40 minutes) Blood pressure, pulse rate, body temperature, SpO2, pCO2 every 5 minutes from the start of device use until 40 minutes after device use Appearance and severity of nausea, vomiting, fatigue, cough, dyspnea, and palpitations from the start of device use to 40 minutes after device use (CTCAE v5.0)

—

Secondary

Measure	Time frame
Blood flow increase rate determined by laser Doppler Time taken to return to pre-administration values using laser Doppler	—

Contacts

Public ContactKeisuke Oe

Kobe University Hospital

keisukeo@med.kobe-u.ac.jp+81-78-382-5985

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026