Hypoxia and Hemodilution Testing in Healthy Adult Volunteers
1 other identifier
observational
7
1 country
1
Brief Summary
This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
March 31, 2026
March 1, 2026
10 months
March 25, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collection of Hemoglobin and Oxygen Saturation Measurements
Collect device readings of oxygen saturation and hemoglobin concentration and reference values obtained from arterial blood samples analyzed using a multi-wavelength laboratory oximeter.
From enrollment to the end of treatment up to 8 hours
Study Arms (1)
Adult healthy subjects
Adult healthy subjects capable of undergoing controlled hypoxemia and hemodilution procedures.
Interventions
Octopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe
Eligibility Criteria
Healthy adult volunteers. At least 7 subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.
You may qualify if:
- In good general health with no evidence of significant medical problems.
- Fluent in both written and spoken English.
- \. Has provided written informed consent and is willing to comply with study procedures.
You may not qualify if:
- BMI above 30.
- History of heart, lung, kidney, or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Diabetes mellitus.
- Clotting disorders.
- Hemoglobinopathy or history of anemia (ctHb \<12 g/dL for men, \<11 g/dL for women, COHb \>2%).
- Any serious systemic illness.
- Current smoker.
- Injury or abnormality at sensor sites interfering with measurements.
- History of fainting or vasovagal response.
- Sensitivity to local anesthesia.
- Diagnosis of Raynaud's disease.
- Unacceptable collateral circulation (Allen's test).
- Pregnant, lactating, or attempting to become pregnant.
- Unable or unwilling to provide informed consent or comply with study procedures.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nihon Kohdenlead
Study Sites (1)
Vital Sign Research Group
San Francisco, California, 94107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Week
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2026
First Posted
March 31, 2026
Study Start
April 2, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Company confidential