A Urine Sample Collection Study in Apparently Healthy Adults and Adults With Chronic, Stable Morbidities

Last updated: May 1, 2023
Sponsor: Astute Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Urine collection for NEPHROCLEAR CCL14 Test

Clinical Study ID

NCT05853016
AST-017
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this study is collect urine samples from healthy adult subjects and subjects with stable chronic morbidities for future testing to serve as controls and establish reference ranges in the development of new invitro diagnostic devices.

Eligibility Criteria

Inclusion

Cohort A Inclusion Criteria:

  1. Apparently healthy adults (age > 21 years);
  2. Provide written informed consent for study participation.

Exclusion

Exclusion Criteria:

  1. Any known or suspected acute illness or condition - including acute infections - atthe time of enrollment or within the previous 30 days;
  2. Any known or suspected significant new onset or chronic morbid medical condition suchas those listed in the inclusion criteria for Cohort B;
  3. Trauma-related surgery within the last 6 months;
  4. Any surgery, hospitalization or institutionalization (such as in a nursing home)during the previous 3 months;
  5. Received any blood product transfusion within the previous 2 months;
  6. Pregnant women or children;
  7. Prisoners or institutionalized individuals;
  8. Already provided a urine sample for this study. Cohort B Inclusion Criteria:
  9. Adults (age > 21 years);
  10. One or more of the following chronic, stable morbid conditions: i. Active cancer ii. Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) iii. Chronic coagulation abnormality iv. Chronic obstructive pulmonary disease (includingemphysema, chronic bronchitis, and asthma) v. Chronic pancreatitis vi. Chronic renalinsufficiency vii. Congestive heart failure viii. Coronary artery disease ix. Diabetesmellitus (Type 1 or Type 2) x. Gout xi. Hyper- or hypothyroidism xii. Hyperlipidemia (includes hypercholesterolemia) xiii. Hypertension xiv. Immunocompromised xv. Inflammatorybowel disease (including Crohn's disease and ulcerative colitis) xvi. Liver cirrhosis xvii.Neuromuscular disease xviii. Peripheral vascular disease (a.k.a. peripheral artery disease) xix. Polycystic kidney disease xx. Rheumatoid arthritis xxi. Systemic Lupus Erythematosus c. Provide written informed consent for study participation. Exclusion Criteria:
  11. Any known or suspected acute illness or condition - including acute infections - atthe time of enrollment or within the previous 30 days;
  12. Any new onset or unstable morbidities;
  13. Trauma-related surgery within the last 6 months;
  14. Any surgery, hospitalization or institutionalization (such as in a nursing home)during the previous 3 months;
  15. Received any blood product transfusion within the previous 2 months;
  16. Pregnant women or children;
  17. Prisoners or institutionalized individuals;
  18. Already provided a urine sample for this study.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Urine collection for NEPHROCLEAR CCL14 Test
Phase:
Study Start date:
March 21, 2022
Estimated Completion Date:
May 31, 2023

Connect with a study center

  • Cyn3rgy Research

    Gresham, Oregon 97030
    United States

    Active - Recruiting

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