Establish ProLung Test Measurement Collection Protocol for Future Studies.

NCT04134520 | Unknown FDA Device

• 1 other identifier: PL 210
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up Validation studies that will assess device accuracy using the new measurement collection methods.

Conditions

Cancer , Healthy

Outcome Measures

Primary Outcomes (1)

• Establish the ProLung Test measurement collection protocol for future studies.

  The study will evaluate several data collection methodologies including the China CFDA Study method which utilizes diaphoretic electrodes as the reference electrode at measurement point locations and other methods using brass reference electrode at point locations. In addition, the benefits of obtaining multiple repeat measurements will be evaluated.

  1 day

Secondary Outcomes (1)

• Assess the safety and tolerability of the ProLung Test procedures

  1 day

Study Arms (2)

Generally healthy subjects with no known cancer disorder

Device: ProLung System

Subjects with a pathological diagnosis of cancer

Device: ProLung System

Interventions

ProLung System DEVICE

Non-invasive bioconductance measurements

Generally healthy subjects with no known cancer disorder; Subjects with a pathological diagnosis of cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign

You may qualify if:

• Study Objectives 2.1 Objectives and Aims The purpose of this Study is to identify and test different data collection methods to determine which approaches improve the ProLung Testing procedure and identify approaches that may be useful in evaluating other cancers in addition to lung cancer. Once this Study is complete, the Sponsor plans to evaluate these improvements in future follow up cancer validation studies that will assess device accuracy using the new measurement collection methods.
• The Specific Aim of this study:
• Establish the ProLung Test measurement collection protocol for future studies.
• Subjects who meet all of the following criteria may be enrolled in this Study:
• Subject is male or female, age 18 or older.
• Subjects eligible for enrollment in one of three arms as described herein Arm 1: Generally healthy subjects with no known cancer disorder Arm 2: Subjects with a pathological diagnosis of cancer that have not yet received treatment for cancer Arm 3: Subjects with a finding that is suspicious for cancer and have not been pathologically confirmed for cancer and have not yet received treatment for cancer Arm 4: Subjects with a cancer finding that has been pathologically confirmed as benign
• Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
• Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").

You may not qualify if:

• The following criteria will disqualify a subject from enrollment into this Study:
• Subject has an implanted electronic device in the chest.
• Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
• Subject will have undergone unusually strenuous exercise within 24 hours.
• Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.

Sponsors & Collaborators

• Fresh Medical Laboratories: lead

Study Sites (4)

Coastal Pulmonary Associates

Encinitas, California, 92024, United States

RECRUITING

Loyola Medical University

Maywood, Illinois, 60153, United States

RECRUITING

Ogden Regional Medical Center

Ogden, Utah, 84405, United States

RECRUITING

Michael Garff

Salt Lake City, Utah, 84103, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Michael Garff

CONTACT

385.501.7002; mag@prolunginc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 22, 2019
• Study Start: February 14, 2020
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)