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

16 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

15

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Scheduled Study Visits Completed by Participants
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ecotera Health LLC

Onderzoekers

  • Studie directeur: Melinda B. Chu, M.D. M.B.A., Ecotera Health LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

21 augustus 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 januari 2027

Studieregistratiedata

Eerst ingediend

2 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2026

Eerst geplaatst (Werkelijk)

20 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

16 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • ecotera-1001 (Andere identificatie: ecotera health)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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