NCT07775495|Recruiting
Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure
OMNU
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OMNU
Sponsor study identifier
Secondary identifiers
OTHER · ecotera health
observational
15
1 country
51
Study Start
October 21, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this observational study is to evaluate the feasibility and usability of at-home urine sample collection, preparation, and smartphone imaging using the EcoExposure™ platform in adults. The main questions it aims to answer are: Can participants successfully collect, prepare, and photograph urine samples at home and upload the images using a smartphone app? How consistent is image quality and participant adherence across repeated sampling over approximately 12 weeks? What is the short-term day-to-day variability in optical signals during an intensive daily sampling period? Participants will: Complete electronic consent and a brief intake questionnaire Collect and prepare urine samples at home at scheduled timepoints Capture guided smartphone photographs of the prepared samples Upload the images and provide brief feedback through the TrialKit app Optionally add a small reference solution (spike sample) to one sample for technical evaluation only The study is fully remote and lasts approximately 12 weeks. It is intended for product development and workflow validation purposes only and does not involve any diagnostic or clinical decision-making.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2, 2026
Actual (reported)August 20, 2026
Actual (reported)October 21, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of Scheduled Study Visits Completed by Participants
Percentage of all scheduled study visits completed by each participant during the 84-day study, including the daily sampling period on Days 7-14.
From Day 0 to Day 84
Percentage of Completed Study Visits With All Required Study Data
Percentage of completed study visits containing all required study data, including recording required urine sample information and uploading images to the secure study app. This measure will be used to assess the feasibility of the decentralized at-home study workflow.
Throughout the study (Day 0 to Day 84)
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
All participants complete the same decentralized urine collection, preparation, and smartphone imaging workflow at scheduled timepoints over approximately 12 weeks. An optional technical reference (spike) sample may be offered; participants who choose this option add a small volume of a known-concentration reference solution to one prepared urine sample before imaging. This optional step is for internal assay and workflow evaluation only and does not create a separate analysis group or change the primary study procedures.
Adults aged 18 years and older who are willing and able to collect and prepare urine samples at home, capture smartphone photographs of the prepared samples, and upload the images through a mobile application. Participants may have common medical conditions; the ability to complete the study procedures is the primary requirement.
Decentralized / At-Home Participation (U.S.)
Birmingham, Alabama, 35005, United States
Decentralized / At-Home Participation (U.S.)
Anchorage, Alaska, 99501, United States
Melinda B. Chu, M.D. M.B.A.
Ecotera Health LLC
First Submitted
August 2, 2026
First Posted
August 20, 2026
Study Start
October 21, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2026
EstimatedUsability Evaluation of the Intelligent Fingerprinting Drug Screening System
Across all scheduled timepoints (Day 0 to Day 84)
Participant Rating of Ease of Using the At-Home Urine Collection and Imaging Workflow
Across all scheduled timepoints (Day 0 to Day 84)
Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling
Day 7-14
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
Day 0 through Day 84, at the study visit when optional spiked-sample testing is performed
Contact the study team to confirm eligibility.
Decentralized / At-Home Participation (U.S.)
Phoenix, Arizona, 85001, United States
Decentralized / At-Home Participation (U.S.)
Little Rock, Arkansas, 72295, United States
Decentralized / At-Home Participation (U.S.)
San Francisco, California, 94102, United States
Decentralized / At-Home Participation (U.S.)
Denver, Colorado, 80014, United States
Decentralized / At-Home Participation (U.S.)
Hartford, Connecticut, 06105, United States
Decentralized / At-Home Participation (U.S.)
Dover, Delaware, 19901, United States
Decentralized / At-Home Participation (U.S.)
Washington D.C., District of Columbia, 20001, United States
Decentralized / At-Home Participation (U.S.)
Miami, Florida, 33101, United States
Decentralized / At-Home Participation (U.S.)
Atlanta, Georgia, 30303, United States
Decentralized / At-Home Participation (U.S.)
Honolulu, Hawaii, 96801, United States
Decentralized / At-Home Participation (U.S.)
Boise, Idaho, 83702, United States
Decentralized / At-Home Participation (U.S.)
Chicago, Illinois, 60601, United States
Decentralized / At-Home Participation (U.S.)
Indianapolis, Indiana, 46201, United States
Decentralized / At-Home Participation (U.S.)
Des Moines, Iowa, 50301, United States
Decentralized / At-Home Participation (U.S.)
Kansas City, Kansas, 66101, United States
Decentralized / At-Home Participation (U.S.)
Louisville, Kentucky, 40201, United States
Decentralized / At-Home Participation (U.S.)
New Orleans, Louisiana, 70112, United States
Decentralized / At-Home Participation (U.S.)
Augusta, Maine, 04330, United States
Decentralized / At-Home Participation (U.S.)
Baltimore, Maryland, 21201, United States
Decentralized / At-Home Participation (U.S.)
Boston, Massachusetts, 02108, United States
Decentralized / At-Home Participation (U.S.)
Detroit, Michigan, 48201, United States
Decentralized / At-Home Participation (U.S.)
Minneapolis, Minnesota, 55401, United States
Decentralized / At-Home Participation (U.S.)
Jackson, Mississippi, 39201, United States
Decentralized / At-Home Participation (U.S.)
St Louis, Missouri, 63117, United States
Decentralized / At-Home Participation (U.S.)
Billings, Montana, 59101, United States
Decentralized / At-Home Participation (U.S.)
Omaha, Nebraska, 68102, United States
Decentralized / At-Home Participation (U.S.)
Las Vegas, Nevada, 89101, United States
Decentralized / At-Home Participation (U.S.)
Manchester, New Hampshire, 03101, United States
Decentralized / At-Home Participation (U.S.)
Newark, New Jersey, 07102, United States
Decentralized / At-Home Participation (U.S.)
Albuquerque, New Mexico, 87101, United States
Decentralized / At-Home Participation (U.S.)
New York, New York, 10003, United States
Decentralized / At-Home Participation (U.S.)
Charlotte, North Carolina, 28202, United States
Decentralized / At-Home Participation (U.S.)
Fargo, North Dakota, 58102, United States
Decentralized / At-Home Participation (U.S.)
Cincinnati, Ohio, 45242, United States
Decentralized / At-Home Participation (U.S.)
Oklahoma City, Oklahoma, 73102, United States
Decentralized / At-Home Participation (U.S.)
Portland, Oregon, 97201, United States
Decentralized / At-Home Participation (U.S.)
Philadelphia, Pennsylvania, 19102, United States
Decentralized / At-Home Participation (U.S.)
Providence, Rhode Island, 02903, United States
Decentralized / At-Home Participation (U.S.)
Charleston, South Carolina, 29401, United States
Decentralized / At-Home Participation (U.S.)
Sioux Falls, South Dakota, 57104, United States
Decentralized / At-Home Participation (U.S.)
Nashville, Tennessee, 37201, United States
Decentralized / At-Home Participation (U.S.)
Houston, Texas, 77002, United States
Decentralized / At-Home Participation (U.S.)
Salt Lake City, Utah, 84101, United States
Decentralized / At-Home Participation (U.S.)
Burlington, Vermont, 05401, United States
Decentralized / At-Home Participation (U.S.)
Virginia Beach, Virginia, 23451, United States
Decentralized / At-Home Participation (U.S.)
Seattle, Washington, 98101, United States
Decentralized / At-Home Participation (U.S.)
Charleston, West Virginia, 25301, United States
Decentralized / At-Home Participation (U.S.)
Milwaukee, Wisconsin, 53202, United States
Decentralized / At-Home Participation (U.S.)
Cheyenne, Wyoming, 82001, United States
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 1, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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