NCT04013126

Brief Summary

Endometriosis is a chronic disease defined as an ectopic endometrial tissue outside the, and associated with chronic inflammatory state and increased risk of atherosclerosis. Endothelial dysfunction plays an important and elementary role in the development of atherosclerosis. There are number of non-invasive tests for evaluating the endothelial function. One of them is FMD - "Flow Mediated Dilatation". Clinical studies proved the efficacy of this method in predicting cardio-vascular events in patients with established heart disease and also as an independent risk factor, better than the traditional ones. An alternative method, developed in recent years, is evaluation of peripheral blood vessels tone - "Peripheral Arterial Tonometry" - (PAT). It evaluates the pulsatile blood volume of the blood vessels in the fingertips during reactive hyperemia. The obtained value "reactive hyperemic index" (RHI) correlates well with FMD as well with coronary arteries endothelial dysfunction. it well suited as a clinical tool or as a test for a large-scale clinical study. Endothelial dysfunction has been demonstrated among woman with endometriosis. After surgical removal of endometrial implants there was a substantial improvement in the endothelial function, by imaging (using FMD) and by inflammatory markers In this study the investigators will follow the endothelial function among women undergoing endometrial implants surgical removal, before and after the surgery, using PAT technology (ENDOPAT system). Inflammatory markers and quality of life parameters will also be evaluated. The follow-up will include one meeting 6 weeks after the procedure The investigators expect an improvement in the endothelial function among women who had endometriosis implants removal.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 12, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

4.1 years

First QC Date

July 4, 2019

Last Update Submit

September 20, 2023

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

  • Change from baseline endothelial function at 6 weeks

    RHI index - "Reactive Hyperemia Index"

    before and 6 weeks after surgery

  • Change from baseline inflammatory markers at 6 weeks

    C-reactive protein

    before and 6 weeks after surgery

Secondary Outcomes (2)

  • Change from baseline pain score at 6 weeks

    before and 6 weeks after surgery

  • Change from baseline quality of life score at 6 weeks

    before and 6 weeks after surgery

Study Arms (2)

endometriosis

EXPERIMENTAL

Women who undergoing surgery for removal of endometriosis implants

Diagnostic Test: • Endothelial function using ENDOPAT system

non-endometriosis

ACTIVE COMPARATOR

Women who undergoing surgery for removal of benign masses in the pelvis

Diagnostic Test: • Endothelial function using ENDOPAT system

Interventions

• Endothelial function using ENDOPAT systemDIAGNOSTIC_TEST

All of the participants will follow an non-invasive test for endothelial function using ENDOPAT 2000 device before surgery. A consecutive assessment will be held 6 weeks and 2 years post-surgery, using the same method.

endometriosisnon-endometriosis

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women who undergoing surgery for removal of endometriosis implants

You may not qualify if:

  • Women under 18 or above 60 years of age
  • Women with known vascular disease
  • Women with chronic disease which effect the endothelial function (Diabetes mellitus, Hypertension, Obesity (Defined as BMI≥30), Atherosclerosis, Kidney disease, Collagen disease, Chronic inflammatory disease, and Etc.
  • History of Cardio-vascular event or venous thromboembolism (VTE)
  • Smoking
  • Pregnant women or gave birth in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Eyal Rom, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 2 groups (treatment, control) each group is evaluated pre and post-surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

August 12, 2019

Primary Completion

September 13, 2023

Study Completion

September 13, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

IL(1)