Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure (OMNU)

August 16, 2026 updated by: Ecotera Health LLC

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a decentralized, observational, product-development study evaluating the EcoExposure™ platform for at-home urine sample collection, preparation, and smartphone-based imaging. The study is non-clinical and is not intended to diagnose, treat, or provide health risk assessments.

Approximately [X] adult participants will be enrolled for a duration of about 12 weeks. All activities are performed remotely using the participant's own smartphone and the TrialKit platform for electronic consent, guided workflows, image capture, and data submission.

Participants will collect and prepare fresh urine samples at home according to provided instructions, capture guided photographs of the prepared samples, and upload the images along with brief feedback. Sampling occurs at the following timepoints: Day 0 (baseline), daily from Day 7 through Day 14 (intensive short-term variability assessment), and then at Days 21, 28, 42, 56, 70, and 84.

An optional technical reference ("spike") sample may be offered. Participants who choose this option will add a small volume of a known-concentration reference solution to one of their prepared urine samples before imaging. This step is solely for internal assay and workflow evaluation and will not be used for any clinical interpretation.

Primary focus areas include participant adherence and completion rates, image quality and usability, workflow feasibility in a fully remote setting, and qualitative assessment of optical signal consistency over time (including comparison of native versus optionally spiked samples for internal development purposes only).

No diagnostic claims, clinical endpoints, or treatment recommendations are involved. Results will support product development, workflow optimization, and assay calibration.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35005
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
        • Principal Investigator:
          • Mona Ascha, M.D.
    • Alaska
      • Anchorage, Alaska, United States, 99501
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
        • Principal Investigator:
          • Mona Ascha, M.D.
    • Arizona
      • Phoenix, Arizona, United States, 85001
        • Decentralized / At-Home Participation (U.S.)
    • Arkansas
      • Little Rock, Arkansas, United States, 72295
        • Decentralized / At-Home Participation (U.S.)
        • Principal Investigator:
          • Mona Ascha, M.D.
    • California
      • San Francisco, California, United States, 94102
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80014
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
        • Principal Investigator:
          • Mona Ascha, M.D.
    • Delaware
      • Dover, Delaware, United States, 19901
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20001
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Florida
      • Miami, Florida, United States, 33101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Hawaii
      • Honolulu, Hawaii, United States, 96801
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83702
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46201
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Iowa
      • Des Moines, Iowa, United States, 50301
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40201
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Maine
      • Augusta, Maine, United States, 04330
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02108
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55401
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Mississippi
      • Jackson, Mississippi, United States, 39201
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63117
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Montana
      • Billings, Montana, United States, 59101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68102
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • New Hampshire
      • Manchester, New Hampshire, United States, 03101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • New York
      • New York, New York, United States, 10003
        • Decentralized / At-Home Participation (U.S.)
        • Principal Investigator:
          • Mona Ascha, M.D.
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28202
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Decentralized / At-Home Participation (U.S.)
        • Principal Investigator:
          • Mona Ascha, M.D.
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97201
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37201
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Texas
      • Houston, Texas, United States, 77002
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Virginia
      • Virginia Beach, Virginia, United States, 23451
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98101
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53202
        • Decentralized / At-Home Participation (U.S.)
        • Contact:
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Decentralized / At-Home Participation (U.S.)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • Able to provide electronic informed consent
  • Willing and able to collect and prepare urine samples at home according to study instructions
  • Own a smartphone capable of running the TrialKit application and capturing photographs
  • Willing to complete the required study visits over approximately 12 weeks

Exclusion Criteria:

  • Unable or unwilling to perform the study procedures (urine collection, sample preparation, smartphone imaging, and data upload)
  • Any condition or circumstance that, in the judgment of the investigator, would prevent the participant from successfully completing the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
EcoExposure Urine Observational Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Scheduled Study Visits Completed by Participants
Time Frame: From Day 0 to Day 84
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
Time Frame: Throughout the study (Day 0 to Day 84)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Time Frame: Across all scheduled timepoints (Day 0 to Day 84)
Percentage of uploaded urine sample images that meet predefined image quality criteria for analysis using the EcoExposure™ image-analysis method.
Across all scheduled timepoints (Day 0 to Day 84)
Participant Rating of Ease of Using the At-Home Urine Collection and Imaging Workflow
Time Frame: Across all scheduled timepoints (Day 0 to Day 84)
Participants will rate the ease of using the at-home urine collection and imaging workflow on a 5-point rating scale from 1 to 5, with higher scores indicating greater ease of use.
Across all scheduled timepoints (Day 0 to Day 84)
Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling
Time Frame: Day 7-14
Urine samples will be measured using the EcoExposure™ optical assay and an image-analysis method that analyzes photographs of the samples. The study will compare how microplastic- and nanoplastic-related optical measurements change within the same participant during daily urine sampling (Days 7-14).
Day 7-14

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
Time Frame: Day 0 through Day 84, at the study visit when optional spiked-sample testing is performed
When the optional spiked sample (urine sample where additional microplastic solution is added to the urine sample using an eyedropper) is performed, the participant's native urine sample and the spiked urine sample will be measured using the EcoExposure™ optical assay and image-analysis method. Optical measurements from the native and spiked samples will be compared to evaluate differences in assay response at different microplastic and nanoplastic levels.
Day 0 through Day 84, at the study visit when optional spiked-sample testing is performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ecotera Health LLC

Investigators

  • Study Director: Melinda B. Chu, M.D. M.B.A., Ecotera Health LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 21, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 2, 2026

First Submitted That Met QC Criteria

August 16, 2026

First Posted (Actual)

August 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 16, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ecotera-1001 (Other Identifier: ecotera health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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