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Completed

NCT Number: NCT03240926

Loop Band Validation Study

The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

About this study

The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband. This wristband (Loop Band) uses optical sensors and spectrometry to measure and estimate vitals as well as a full blood gas panel; comparable to the standard method of an invasive arterial line and pressure transducer. The investigators aim to show equivalence of clinical physiologic outcome measurements with the Loop Band relative to current methods (i.e. arterial lines, etc.). In addition, this study aims to validate this wearable technology as a potential alternative to invasive measurements, to reduce complications, and improve accuracy in regards to patient monitoring.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has capacity to consent for the study.
  • Anesthetic plan for an arterial line for vital sign monitoring during their surgical procedure.

Exclusion criteria

  • Active Atrial Fibrillation
  • Active C-difficile
  • Amputation of the arm at the wrist or above
  • The Investigator and/or Clinical Research Nurse will conduct a visual inspection for attributes that may diminish device accuracy. These include but are not limited to: tattoos over the radial artery, burns or heavy scarring over the radial artery, fragile skin, any skin diseases affecting the wrist or arm, Physician discretion-any condition deemed inappropriate that will preclude use of the device.

Treatment and study plan

Loop Band

Device

Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.

Primary outcomes

  1. Device Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate) measured by Arterial Line.

    Time frame: intraoperative

    Equivalence in clinical outcome measures (heart rate, blood oxygenation, carboxyhemoglobin level, end tidal carbon dioxide, and respiratory rate etc.) with the Loop Band relative to current methods (i.e. arterial lines, etc.) during a surgical procedure.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: intraoperative

    Evaluate safety data based on reported Adverse Events (AEs).

Sponsors and collaborators

Lead sponsor

Spry Health

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2017
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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