Recruiting

ProLung Test

Sponsor:

Fresh Medical Laboratories

Code:

NCT04134520

Conditions

Cancer , Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ProLung System

Study Details

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

Study ID

NCT04134520

Start date

Feb 14, 2020

Status verified date

Oct, 2022

Completion date

Oct 16, 2024

Anticipated

Primary completion date

Oct 16, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

7 2.0 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:

1. Establish the ProLung Test measurement collection protocol for future studies.
2. Assess the safety and tolerability of the ProLung Test procedures. 3.0 Study Design This Study Non-Interventional Observational Multi-Site Study in which the ProLung Test does not affect, influence or alter the subject's normal standard of care. The Study will collect data from multiple sites (1- 15). The Study will enroll a minimum of 100 and a maximum 500 subjects. Each subject will receive one or multiple measurement sessions on separate days. 3.1 Safety and Tolerability Information collected about adverse events and tolerability will be analyzed as described in sections 5.8 and 6.0 (Additional Data Collection and Adverse Events). 3.2 Monitoring The study Sponsor will provide monitors to monitor Protocol compliance and provide guidance pertaining to the management of the Study. 4.0 Subject Selection and Participation 4.1 Inclusion Criteria

Subjects who meet all of the following criteria may be enrolled in this Study:

1. Subject is male or female, age 18 or older.
2. 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
3. Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
4. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").

Exclusion Criteria:

The following criteria will disqualify a subject from enrollment into this Study:

1. Subject has an implanted electronic device in the chest.
2. Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
3. Subject will have undergone unusually strenuous exercise within 24 hours.
4. 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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Generally healthy subjects with no known cancer disorder

Subjects with a pathological diagnosis of cancer

Interventions

ProLung System

Non-invasive bioconductance measurements

Primary outcome measure

  • Establish the ProLung Test measurement collection protocol for future studies. [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

Coastal Pulmonary Associates

Recruiting

Encinitas, California, United States, 92024

Contacts

Loyola Medical University

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Principal Investigator:

Amit Goyal, M.D.

Ogden Regional Medical Center

Recruiting

Ogden, Utah, United States, 84405

Contacts

Principal Investigator:

Jose Perez-Tomayo, M.D.

Michael Garff

Recruiting

Salt Lake City, Utah, United States, 84103

Contacts

Principal Investigator:

Rex Yung, M.D.

More Information

Sponsor

Fresh Medical Laboratories

Last update posted

Oct 25, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fresh Medical Laboratories on 2022-10-25.