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Home COPD and Open Ventilation Evaluation (HOPE) Study

NCT03691181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-10-03

No results posted yet for this study

Summary

Respiratory related diseases such as chronic obstructive pulmonary disease (COPD) and neuromuscular diseases remain a major public health issue affecting millions of people worldwide. More than 15 million people are estimated to be diagnosed with COPD in the US alone. In the US, the direct and indirect costs associated with COPD are estimated to be about $50 billion. Clinical studies have shown that by providing ventilation to reduce respiratory insufficiency symptoms such as dyspnea, patients may become more tolerant to exercise and be able to increase their participation in activities of daily living resulting in an overall positive impact in their quality of lives. The Life2000 Ventilation System, with the smallest tubing and comfortable interface solutions, is the only ventilator to simultaneously provide full ventilatory support and enable patients to ambulate.

The Life2000 Ventilation System is an FDA-cleared critical care ventilator (K141943/S003, June 2015) indicated for use for adult patients who require positive pressure ventilation delivered invasively or non-invasively. The device, classified by FDA as a continuous ventilator, can treat both acute and chronic respiratory failure and is suitable for use in home and institutional settings by qualified, trained personnel under the direction of a physician.

The Life2000 Compressor is intended to provide a 50-psi pressure source to the ventilator and is currently in the FDA premarket notification (510 k) clearance process, so its use is considered investigational.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

Ventilation

monitoring with the use of the Life2000 Ventilation System for a period of six months

Sponsors & Collaborators

  • Breathe Technologies, Inc.

    collaborator INDUSTRY

  • Landon Pediatric Foundation

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-06-30
Completion
2018-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03691181 on ClinicalTrials.gov