Recruiting

Aktiia.product-G1-US

Sponsor:

Aktiia SA

Code:

NCT07507903

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 22 - 59

Healthy Volunteers: Accepted

Interventions

Device under test evaluation against references

Study Details

Brief summary:

This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7 days after initialization in a cohort of subjects representative of the US population.

Conditions

Hypertension

Study ID

NCT07507903

Start date

Apr 14, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 59

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Participants must be able to provide informed consent to participate.
2. Participants must be willing and able to comply with all of the study procedures and return for a second visit one week later.
3. Participants must be 22 to 59 years of age.
4. Participants or witnesses must be able to read or write in English.

Exclusion Criteria:
5. Participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
6. Female participants who are known to be pregnant or who are trying to get pregnant confirmed by a visit 1 and, if applicable, visit 2 positive urine pregnancy test, unless the study participants are known to be not of child-bearing potential .
7. Participants with known history of clotting disorders or blood clots, or currently taking a prescription blood thinner.
8. Other known health conditions that will prevent safe participation in the study upon disclosure in Health Assessment Short Form or verbally.
9. Participants suffering from sporadic or sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including but not limited to tachycardia (heart rate at rest > 120bpm) and atrial fibrillation.
10. Participants suffering from sporadic or sustained reduction of peripheral perfusion that can lead to weak or unstable pressure pulses including but not limited to: Raynaud's disease, diabetes (Type I and Type II), renal dysfunctions (eGFR < 60mL / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma, arteriovenous fistula, and valvular heart diseases.
11. A wrist circumference below 14 cm or above 23 cm.
12. An upper-arm circumference <22 cm or > 42cm.
13. Any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study.
14. Any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, or bias the results, by instance a subject presenting a lateral Blood Pressure difference at screening of more than 15 mmHg for the systolic and/or more than 10 mmHg for the diastolic.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Aktiia.product-G1-US device under test

Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references.

Interventions

Device under test evaluation against references

Blood pressure and pulse rate measurements will be taken at different timepoints with the device under test and references. Main references: Cuff for double auscultation for blood pressure and Electrocardiogram for pulse rate.

Primary outcome measure

  • Blood pressure mean value of differences [ Time Frame: 7 days ]
  • Blood pressure standard deviation of differences [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Anne Fedor Chief Clinical Research Officer

303-993-5217anne@parameterslab.com

Locations

Parameters Research Laboratory

Recruiting

Broomfield, Colorado, United States, 80021

Contacts

More Information

Sponsor

Aktiia SA

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • blood pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Aktiia SA on 2026-09-14.