Clinical trial NCT04134520: Establish ProLung Test Measurement Collection Protocol for Future Studies.
Official title: PL-210: Establish ProLung Test Measurement Collection Protocol for Future Studies.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer , Healthy
Lead sponsor: Fresh Medical Laboratories
Sponsor class: INDUSTRY
First posted: 2019-10-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Establish the ProLung Test measurement collection protocol for future studies.
timeFrame: 1 day
Secondary outcomes:
measure: Assess the safety and tolerability of the ProLung Test procedures
timeFrame: 1 day
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Coastal Pulmonary Associates
state: California
city: Maywood
country: United States
facility: Loyola Medical University
state: Illinois
city: Ogden
country: United States
facility: Ogden Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: Michael Garff
state: Utah
Study officials:
References: