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Objective Pain Measurement Using a Wearable Biosensor and a Mobile Platform in Patients With Endometriosis (OPINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318275
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by (Responsible Party):
Biofourmis Singapore Pte Ltd.

Brief Summary:
This study aims to explore a novel objective measurement for endometriosis-related pain. 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, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, pain beyond the pelvis, endometriosis diagnosis, or severity of pain using operative findings and a standardized classification system.

Condition or disease
Endometriosis

Detailed Description:

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, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, and pain beyond the pelvis, and endometriosis diagnosis and severity using operative findings and a standardized classification system.

Historically, pain has been measured using subjective scales to determine the presence of pain and its severity. Common scales include the numeric rating scale (NRS), visual analog scale (VAS), and visual response scale (VRS) While this is important information, self-reporting is a problematic metric for both diagnostic and research purposes as it depends on pain history, cognitive and behavioral factors, and can vary over time. Other measures used in clinical practice, such as the Biberoglu and Behrman (B&B) score, incorporate both patient and clinician assessments of pain. However, patients describe symptomatology and gynecologists evaluate tenderness and induration during physical examination with an exceedingly high risk of bias and inconsistent reproducibility. Over the past few years, significant advances have been made in the development of valid biomarkers or surrogate markers for the presence and severity of pain. Measurement of various physiology parameters like heart rate, heart rate variability and electrodermal activity have shown to be associated with the presence of pain and can aid clinical interpretation.

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Study Type : Observational
Estimated Enrollment : 124 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: An Early Feasibility Study to Explore a Novel Objective Pain Measurement Using a Wearable Biosensor and a Novel Mobile Platform in Patients With Endometriosis (OPINE)
Estimated Study Start Date : June 2, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis




Primary Outcome Measures :
  1. The concordance rate between Pain Index and NRS scores during the study period [ Time Frame: 12 weeks ]
    Pain Index will be generated via vitals sign( Electrodermal Activity, Heart Rate and Respiration Rate) collected from the subjects and processed by Biofourmis's propriety algorithm. Both pain index and NRS will be categorised into none (0), mild (1-3), moderate (4-7) and severe pain(8-10)


Secondary Outcome Measures :
  1. Correlation between Pain Index and NRS score [ Time Frame: 12 weeks ]
    We will take the absolute value of each of these scores and perform a Pearson's correlation on it.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female on self-representation and confirmed diagnosis of endometriosis by TVUS or MRI.
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
124 study participants, aged between 21 to 50 years old, female, who is confirmed diagnosis of endometriosis.
Criteria

Inclusion criteria

  1. Able to give a written Informed Consent Form.
  2. 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)
  3. Female patients aged ≥ 21 and < 50 years.
  4. Confirmed diagnosis of endometriosis (laparoscopy/laparotomy) performed within 10 years prior to the study participation or current clinical diagnosis (endometriotic cysts or deep infiltrating endometriosis detected by TVUS or MRI) within 6 months prior to the study participation.
  5. Patient who meets either A or B in the following criteria:

    A. 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 study participation.

    B. 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:

  1. 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.
  2. 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).
  3. Patient has more than five surgical histories in pelvic area.
  4. Patient has a skin disease or condition that would interfere with the collection or interpretation of physiological data obtained through E4® wearable device.
  5. Patient required neuromodulator (a long-acting or immediate release narcotic, or gabapentin) during 3 months prior to the study participation.
  6. Patient has a planned surgery during the study.
  7. Patient had a surgery within 4 weeks prior to the study pariticipation.
  8. Patient has a planned trip overseas during the study participation.
  9. Any other reason that, in the judgment of the investigator, would render the subject unsuitable for the study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318275


Contacts
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Contact: Rachel Chan 62536306 ext 201 rachel@biofourmis.com
Contact: Jackie Velarde 62536306 ext 204 jackie.velarde@biofourmis.com

Locations
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United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Contact: megan Wasson, DO         
Contact    480-342-0612    Wasson.Megan@mayo.edu   
Principal Investigator: Megan Wasson, Ass Prof         
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Contact: Tatnai Burnett, M.D.    507-538-5783    Burnett.Tatnai@mayo.edu   
Principal Investigator: Tatnai Burnett, M.D.         
Singapore
National University Hospital
Singapore, Singapore, 119074
Contact: li Ma, Doctor    6779 5555    li_ma@nuhs.edu.sg   
Principal Investigator: Li Ma, Dr         
Singapore General Hospital
Singapore, Singapore, 169608
Contact: Sun Kuie Tay    6222 3322    ay.sun.kuie@singhealth.com.sg   
Principal Investigator: Sun Kui Tay, Pro         
Sponsors and Collaborators
Biofourmis Singapore Pte Ltd.
Chugai Pharmaceutical
Publications:

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Responsible Party: Biofourmis Singapore Pte Ltd.
ClinicalTrials.gov Identifier: NCT04318275    
Other Study ID Numbers: CT004-AMY004JG
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female