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

16 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

15

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Scheduled Study Visits Completed by Participants
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ecotera Health LLC

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

21 augusti 2026

Primärt slutförande (Beräknad)

31 december 2026

Avslutad studie (Beräknad)

31 januari 2027

Studieregistreringsdatum

Först inskickad

2 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

16 augusti 2026

Första postat (Faktisk)

20 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • ecotera-1001 (Annan identifierare: ecotera health)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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