HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-14

Study Completion Date

2037-06-01

Brief Summary

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Endometriosis (EMS) is a common gynecological disease that affects 176 million girls and women globally. EMS affects 5-10% of women and adolescents within the reproductive age range of 15-49 years, and for those facing infertility, this figure may climb up to 50%. EMS can start at the first menstrual period and last until menopause. Shockingly, between 50% and 80% of women grappling with pelvic pain are found to have EMS. The formation of scar tissue (adhesions, fibrosis) within the pelvis and other parts of the body can cause severe pain and lead to infertility.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A non-invasive blood-based test

A non-invasive blood-based test to detect endometriosis as compared to diagnostic laparoscopy

Group Type EXPERIMENTAL

A non-invasive blood-based (HerResolve)

Intervention Type DEVICE

A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy

Interventions

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A non-invasive blood-based (HerResolve)

A non-invasive blood-based test can detect endometriosis as compared to diagnostic laparoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Females aged 18 to 49 with mild to severe symptoms of pelvic pain and/or abnormal bleeding.
* Diagnostic laparoscopy is scheduled with histology on any visually suspected endometriosis, and all reports (surgical and pathology) to confirm a positive result. If no visually suspicious endometriotic lesions are seen, biopsies from random areas during the laparoscopy procedure to confirm a negative histopathology result.
* Blood drawn during secretory or proliferative phase of the menstrual cycle
* Provide written informed consent to participate in the study and provide medical history on medications.

Exclusion Criteria

* Patients who object to medical history collection and data requests
* Patients with cancer and/or undergoing chemotherapy and/or radiotherapy
* Patients who are unable or do not undergo laparoscopic surgery
* Patients participating in additional interventional clinical studies
* Pregnant, lactating, or subjects who are not healthy enough for blood donation.
* Blood drawn during menses or ovulation phase of menstrual cycle
* Females who are post-menopausa

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes