NCT03240926

Loop Band Validation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Spry Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	Loop Band	Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.

Timeline

• Start date: 2017-02-21
• Primary completion: 2018-01-22
• Completion: 2018-01-25
• First posted: 2017-08-07
• Last updated: 2018-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study