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Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock

NCT07825363

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

Summary

This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and photoplethysmography (PPG), combined with an electrocardiography/impedance cardiography (ECG/ICG) sensor, to continuously monitor tissue oxygen saturation (StO2), peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, stroke volume, and related metrics.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Cardiogenic Shock
  • Acute Myocardial Infarction
  • Acute Decompensated Heart Failure

Eligibility basics and study details

Study type
Observational
Phase
Not applicable
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
NIRSense Inc.
Last updated on ClinicalTrials.gov
September 17, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 1

  • Cleveland Clinic Florida, Weston Hospital · Weston, FL

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.