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

16. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

15

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Scheduled Study Visits Completed by Participants
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ecotera Health LLC

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

21. august 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. januar 2027

Datoer for studieregistrering

Først indsendt

2. august 2026

Først indsendt, der opfyldte QC-kriterier

16. august 2026

Først opslået (Faktiske)

20. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • ecotera-1001 (Anden identifikator: ecotera health)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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