Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure (OMNU)
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.
Przegląd badań
Status
Status
Warunki
Warunki
Szczegółowy opis
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.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Cameron Y. Research Coordinator, M. Phil
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35005
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: 15132787420
- E-mail: hello@ecoterahealth.com
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Główny śledczy:
- Mona Ascha, M.D.
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Alaska
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Anchorage, Alaska, Stany Zjednoczone, 99501
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: 15132787420
- E-mail: hello@ecoterahealth.com
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Główny śledczy:
- Mona Ascha, M.D.
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85001
- Decentralized / At-Home Participation (U.S.)
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Arkansas
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Little Rock, Arkansas, Stany Zjednoczone, 72295
- Decentralized / At-Home Participation (U.S.)
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Główny śledczy:
- Mona Ascha, M.D.
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California
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San Francisco, California, Stany Zjednoczone, 94102
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80014
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: 15132787420
- E-mail: hello@ecoterahealth.com
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Connecticut
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Hartford, Connecticut, Stany Zjednoczone, 06105
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: 15132787420
- E-mail: hello@ecoterahealth.com
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Główny śledczy:
- Mona Ascha, M.D.
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Delaware
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Dover, Delaware, Stany Zjednoczone, 19901
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: 15132787420
- E-mail: hello@ecoterahealth.com
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District of Columbia
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Washington D.C., District of Columbia, Stany Zjednoczone, 20001
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Florida
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Miami, Florida, Stany Zjednoczone, 33101
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30303
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96801
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Idaho
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Boise, Idaho, Stany Zjednoczone, 83702
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60601
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46201
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Iowa
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Des Moines, Iowa, Stany Zjednoczone, 50301
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Kansas
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Kansas City, Kansas, Stany Zjednoczone, 66101
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40201
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Louisiana
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New Orleans, Louisiana, Stany Zjednoczone, 70112
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Maine
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Augusta, Maine, Stany Zjednoczone, 04330
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21201
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02108
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55401
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Mississippi
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Jackson, Mississippi, Stany Zjednoczone, 39201
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Missouri
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St Louis, Missouri, Stany Zjednoczone, 63117
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Montana
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Billings, Montana, Stany Zjednoczone, 59101
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68102
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89101
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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New Hampshire
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Manchester, New Hampshire, Stany Zjednoczone, 03101
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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New Jersey
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Newark, New Jersey, Stany Zjednoczone, 07102
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87101
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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New York
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New York, New York, Stany Zjednoczone, 10003
- Decentralized / At-Home Participation (U.S.)
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Główny śledczy:
- Mona Ascha, M.D.
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Kontakt:
- Cameron Y. Research Coordinator, M.Phil
- Numer telefonu: 15132787420
- E-mail: hello@ecoterahealth.com
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28202
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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North Dakota
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Fargo, North Dakota, Stany Zjednoczone, 58102
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45242
- Decentralized / At-Home Participation (U.S.)
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Główny śledczy:
- Mona Ascha, M.D.
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73102
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97201
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19102
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29401
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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South Dakota
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Sioux Falls, South Dakota, Stany Zjednoczone, 57104
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37201
- Decentralized / At-Home Participation (U.S.)
-
Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Texas
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Houston, Texas, Stany Zjednoczone, 77002
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84101
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Vermont
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Burlington, Vermont, Stany Zjednoczone, 05401
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Virginia
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Virginia Beach, Virginia, Stany Zjednoczone, 23451
- Decentralized / At-Home Participation (U.S.)
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Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Washington
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Seattle, Washington, Stany Zjednoczone, 98101
- Decentralized / At-Home Participation (U.S.)
-
Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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West Virginia
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Charleston, West Virginia, Stany Zjednoczone, 25301
- Decentralized / At-Home Participation (U.S.)
-
Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53202
- Decentralized / At-Home Participation (U.S.)
-
Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Wyoming
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Cheyenne, Wyoming, Stany Zjednoczone, 82001
- Decentralized / At-Home Participation (U.S.)
-
Kontakt:
- Cameron Y. Research Coordinator
- Numer telefonu: +15132787420
- E-mail: hello@ecoterahealth.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Scheduled Study Visits Completed by Participants
Ramy czasowe: 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
|
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Percentage of Completed Study Visits With All Required Study Data
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Percentage of Uploaded Urine Sample Images Meeting Predefined Image Quality Criteria
Ramy czasowe: 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
Ramy czasowe: 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)
|
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Change in EcoExposure™ Microplastic and Nanoplastic Optical Measurements During Daily Urine Sampling
Ramy czasowe: 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
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Difference in EcoExposure™ Optical Measurements Between Native and Microplastic/Nanoplastic-Spiked Urine Samples
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Melinda B. Chu, M.D. M.B.A., Ecotera Health LLC
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- ecotera-1001 (Inny identyfikator: ecotera health)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .