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

16. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Antatt)

15

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ecotera Health LLC

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

21. august 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. januar 2027

Datoer for studieregistrering

Først innsendt

2. august 2026

Først innsendt som oppfylte QC-kriteriene

16. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • ecotera-1001 (Annen identifikator: ecotera health)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere