A Study Of Apple Watch Data For Early Fibroid Diagnosis

Overview

About this study

The purpose of this study is to prospectively collect and process Apple Watch data from women with and without fibroids.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • English-speaking adults aged 32–48 years

  • Have a uterus

  • Have experienced a menstrual period in last 90 days

  • Have a Mayo Clinic record number (MRN)

  • Own or have regular access to an iPhone

  • Symptomatic Cohort, participants must :

    • Have a documented diagnosis of uterine fibroids based on ultrasound or MRI imaging completed within the past 5 years.

    • Have a Pictorial Blood Loss Assessment Chart (PBLAC) score >100.

  • Comparison Cohort, participants must:

    • Have no diagnosis of uterine fibroids, based on ultrasound or MRI imaging completed within the past 5 years

    • Have no abnormal uterine bleeding, defined as a PBLAC score <100

  • Participants in both cohorts must be willing to:

    • Wear an Apple Watch continuously, during the day and night, for 3 months.

    • Share their Apple Watch data with a member of the study team via AirDrop to a Mayo Clinic secure MacBook device

    • Complete an in-person study visit in Rochester, Minnesota, at the end of the 3-month participation period

  • Participants who require a study-provided Apple Watch must also:

    • Complete an in-person visit in Rochester, Minnesota, at the start of the 3-month participation period to receive and set up the temporary Apple Watch with a member of the study team

    • Complete an end-of-study in-person visit unless the study team receives Study App Template approval from Apple. If approval is obtained, the end-of-study in-person visit may not be necessary

 

Exclusion Criteria:

  • Are not between the ages of 32-48 years old

  • Do not have a uterus

  • Do not regularly experience menstrual bleeding within the past 90 days

  • Have a intrauterine device (IUD) or use birth control that prevents menstral bleeding

  • Do not have a Mayo Clinic record number (MRN)

  • Are unwilling to wear an Apple Watch or share Apple Watch data

  • Do not own or have regular access to an iPhone

  • Are pregnantat the time of enrollment

  • Beecome pregnant during the study; such individuals witll be excluded or administratively withdraw

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/25/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Shannon Laughlin-Tommaso, M.D.

Contact us for the latest status

More information

Publications

Publications are currently not available
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CLS-20611343

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