OM2 Abbreviated Sensor Verification

NCT06415799 | Completed

• 1 other identifier: MDT23027OM2VAB
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (2)

• Verification of Saturation Accuracy

  Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for the investigational Pulse Oximetry PCBA system, SpO2 across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2% (ARMS) FlexMax ±2.5%(ARMS) DS-100A ±3% (ARMS) D-YS ±3% (ARMS)

  2.5 hours

• Verification of Pulse Rate

  Pulse rate in a diverse subject population over a specified saturation range. The acceptance criteria for pulse rate from 20-250 BPM over a specified saturation range of 70-100%: Pulse Rate Max-A ≤3% BPM (ARMS) OxySoft-N ≤3% BPM (ARMS) Max-Fast ≤3% BPM (ARMS) FlexMax ≤3% BPM (ARMS) DS-100A ≤3% BPM (ARMS) D-YS ≤3% BPM (ARMS)

  2.5 hours

Study Arms (1)

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Male or Female volunteers age 18 to 50 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.

You may qualify if:

• Male or female subjects 18 to 50 years of age
• Subject is willing and able to comply with study procedures and duration
• Subject is willing to sign an informed consent
• Subject weighs \>40kg
• Subject is a non-smoker or has not smoked within 2 days prior to the study
• Cleared same day health assessment form and health screening
• Successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.

You may not qualify if:

• Subject is considered as being morbidly obese (defined as BMI \>39.5)
• Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
• Females of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study
• Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure
• tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure
• MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
• Subjects with known respiratory conditions such as:
• uncontrolled / severe asthma
• flu or influenza type infection
• pneumonia / bronchitis
• shortness of breath / respiratory distress
• unresolved respiratory or lung surgery
• emphysema, COPD, lung disease
• recent COVID (last 2 months)
• Subjects with known heart or cardiovascular conditions such as:

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Element

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica Rabanal

  Element Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 16, 2024
• Study Start: February 11, 2024
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: July 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)