A Study to Evaluate a Wearable Biosensor and Mobile Platform in Endometriosis Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-011719
- Scottsdale/Phoenix, Arizona: 19-011719
NCT ID: NCT04318275
About this study
The purpose of this study is to explore Biovitals™ wearable device and mobile platform’s ability to detect and quantify various levels of endometriosis pain when used in a home-use setting.
A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood.
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:
- Able to give a written Informed Consent Form.
- Patient who is willing to comply with study restrictions including E4® device management (wearing and charging the device) and Femme Rhythm Patient App Management (pairing E4® device and the patient Femme Rhythm App, and carrying the smartphone for answering questionnaires and data reporting).
- Female patients aged ≥ 21 and < 50 years.
- Patient who meets either A or B or both in the following criteria:
- Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed WITHIN 10 YEARS prior to the study participation;
- Current clinical diagnosis (endometriotic cysts or deep infiltrating endometriosis detected by TVUS, TRUS or MRI) WITHIN 6 MONTHS prior to the study participation.
- Patient who meets either A or B in the following criteria:
- Patient is NOT treated with hormonal agents for endometriosis WITHIN 4 WEEKS prior to study participation, and have reqular menses (i.e., 21-38 days) within 38 days prior to the study participation;
- Patient started hormonal agents for endometriosis, including combined oral contraceptives MORE THAN 8 WEEKS prior to the study participation, or progestins, danazol, GnRH agonists, GnRH antagonists or Progesterone and Levonorgestrel Releasing IUDs MORE THAN 12 WEEKS prior to the study participation, AND stable use of the medication is expected during the study period 6. Patient has a moderate to severe endometriosis associated pelvic pain using the Monthly Assessment of Endometriosis Pain within 28 days prior to study participation.
Exclusion Criteria:
- Patient is pregnant, or breast feeding or is planning a pregnancy during participation of the study or is less than 6 months postpartum, post-abortion, or post-pregnancy before participation.
- Patient has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain (e.g., pelvic inflammatory disease).
- Patient has more than five surgical histories in pelvic area.
- Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4®
- Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
- Patient has a planned surgery during the study.
- Patient had a surgery within 4 weeks prior to the study participation.
- Patient has a planned trip overseas during the study participation.
- Any other reason that, in the judgment of the investigator, would render the subject unsuitable for the study participation.
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 Tatnai Burnett, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Megan Wasson, D.O. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available