OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device (OBPM_PANDA2026)

OBPM_PANDA2026: Pivotal Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring (OBPM) Device at Wrist Against Double Auscultation: a Multicenter Prospective Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: Device under test evaluation against references

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Fedor Chief Clinical Research Officer; Phone Number: 303-993-5217; Email: anne@parameterslab.com

Study Locations

• United States
  • Colorado
    • Broomfield, Colorado, United States, 80021
      • Parameters Research Laboratory
      • Contact: Arthur Cabrera Dr Med.; Phone Number: 303-993-5217; Email: art@parameterslab.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure mean value of differences	The mean value of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.	7 days
Blood pressure standard deviation of differences	The standard deviation of the differences between Aktiia.product-G1-US and double auscultation blood pressure measurements.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate root-mean-square error	The root-mean-square difference between the Aktiia.product-G1-US heart rate determinations and the reference method.	7 days

Collaborators and Investigators

• Sponsor: Aktiia SA

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: blood pressure
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: OBPM_PANDA2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No