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Safety evaluation of a lower-limbs artificial negative pressure device in healthy subjects: single-group trial

Safety evaluation of a lower-limbs artificial negative pressure device in healthy subjects: single-group trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240069
Enrollment
15
Registered
2024-06-20
Start date
2024-08-21
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 subjects

Interventions

Five tests will be conducted on the study participants: a sitting test, a standing test, a low-intensity lower-limbs artificial negative pressure (LANP) test, a moderate-intensity LANP test, and a hig

Sponsors

Sakai Yoshitada
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Individuals who have provided consent. 2) Healthy subjects aged 18 years or older but less than 40 years at the time of obtaining consent. 3) Individuals with normal resting blood pressure (systolic blood pressure 100 to 139 mmHg and diastolic blood pressure 60 to 89 mmHg). 4) Normal weight individuals (BMI 18.5 to 24.9).

Exclusion criteria

Exclusion criteria: 1) Individuals who have experienced orthostatic hypotension accompanied by symptoms such as dizziness or nausea in the past 6 months. 2) Individuals with tachyarrhythmic or bradyarrhythmic arrhythmias. 3) Individuals taking cardiovascular medications that affect blood pressure, heart rate, or autonomic nervous activity (antihypertensive drugs, antiarrhythmic drugs, heart failure treatment drugs, etc.). 4) Women who are pregnant, may be pregnant, or are breastfeeding. 5) Others deemed inappropriate for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Presence or absence of adverse events Presence or absence of malfunctions in the test equipment

Secondary

MeasureTime frame
Changes in cardiovascular parameters from rest during LANP loading and gravitational loading

Contacts

Public ContactTakumi Hirabayashi

Kobe University Hospital

hirabayashi@phoenix.kobe-u.ac.jp+81-78-382-6494

Outcome results

None listed

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