Loop Band Validation Study

NCT03240926 | Completed FDA Device

• 1 other identifier: 32315
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; COPD Exacerbation; COPD Asthma; COPD Bronchitis; COPD, Severe Early-Onset

Outcome Measures

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.

  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.

  intraoperative

Secondary Outcomes (1)

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

  intraoperative

Study Arms (1)

Loop Band

EXPERIMENTAL

Measure accuracy of vital sign measurements

Device: Loop Band

Interventions

Loop Band DEVICE

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

Loop Band

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spry Health: lead

Study Sites (1)

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Disease, Chronic Obstructive, Severe Early-Onset

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Harry Bowles, MD

  Spry Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 7, 2017
• Study Start: February 21, 2017
• Primary Completion: January 22, 2018
• Study Completion: January 25, 2018
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)