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Loop Band Validation Study

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ClinicalTrials.gov Identifier: NCT03240926
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Spry Health

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

Condition or disease Intervention/treatment Phase
COPD Device: Loop Band Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Loop Band Validation Study
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : January 22, 2018
Actual Study Completion Date : January 25, 2018

Arm Intervention/treatment
Experimental: Loop Band
Measure accuracy of vital sign measurements
Device: Loop Band
Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: intraoperative ]
    Evaluate safety data based on reported Adverse Events (AEs).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240926


Locations
United States, California
Huntington Memorial Hospital
Pasadena, California, United States, 91105
Sponsors and Collaborators
Spry Health
Investigators
Principal Investigator: Harry Bowles, MD Spry Health

Responsible Party: Spry Health
ClinicalTrials.gov Identifier: NCT03240926     History of Changes
Other Study ID Numbers: 32315
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Spry Health:
COPD
COPD Exacerbation
COPD Asthma
COPD Bronchitis
COPD, Severe Early-Onset