Clinical Study for HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women of Ages 18-49 Years Considering Laparoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Detecting endometriosis as compared to diagnostic laparoscopy
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
A non-invasive blood-based test
A non-invasive blood-based test to detect endometriosis as compared to diagnostic laparoscopy
Intervention: A non-invasive blood-based (HerResolve) (Device)
Outcomes
Primary Outcomes
Detecting endometriosis as compared to diagnostic laparoscopy
Time Frame: 1 week
To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy
Secondary Outcomes
- Performance Objective:(1 year)
Investigators
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong