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

NCT04318275 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2022-05-19

No results posted yet for this study

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.

Conditions

  • Endometriosis

Sponsors & Collaborators

  • Chugai Pharmaceutical

    collaborator INDUSTRY

  • Biofourmis Singapore Pte Ltd.

    lead INDUSTRY

Principal Investigators

  • Maulik Majmudar, M.D. · Biofourmis Inc.

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2021-10-28
Completion
2022-02-22

Countries

  • United States
  • Singapore
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04318275 on ClinicalTrials.gov