EndometriosisNCT04013126
Endothelial Dysfunction Among Woman With Endometriosis
A study testing • Endothelial function using ENDOPAT system in people with Endometriosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- • Endothelial function using ENDOPAT system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Aug 2019to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who undergoing surgery for removal of endometriosis implants
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Dysfunction Among Woman With Endometriosis After Surgical Treatment
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.
Read more
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.
Read the detailed description
Endometriosis is a chronic disease defined as an ectopic endometrial tissue outside the uterus, mostly in the pelvis. It is related to major morbidity and infertility. It is also 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". It refers to dilation (widening) of an artery when blood flow increases in that artery after An intentional block of the blood flow. 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.
The test is performed by attaching two sensors to the patient's fingertips. Using this method requires short training interval, completely user-independent and the accepted result is a quantitive index. Because it takes only 15 minute to complete the test 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, so no difference was shown between them and healthy women, 2 years thereafter.
In a large meta-analysis, evaluating 5,547 patients, every 1% improvement in the FMD scale resulted in a 13% decrease in the rate of cardio-vascular events.
In a meta-analysis evaluating 5,547 patients a 13% reduction in the risk to cardio-vascular events was demonstrated for every 1% improvement in the FMD score.
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.
- Conditions
- Endometriosis
- Being tested
- • Endothelial function using ENDOPAT system
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• 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.
| Study group | Role | What they receive |
|---|---|---|
| endometriosis | Experimental | Women who undergoing surgery for removal of endometriosis implants Receives: Diagnostic Test: • Endothelial function using ENDOPAT system |
| non-endometriosis | Active comparator | Women who undergoing surgery for removal of benign masses in the pelvis Receives: Diagnostic Test: • Endothelial function using ENDOPAT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline endothelial function at 6 weeks
RHI index - "Reactive Hyperemia Index"
Measured: before and 6 weeks after surgery
Change from baseline inflammatory markers at 6 weeks
C-reactive protein
Measured: before and 6 weeks after surgery
Secondary outcomes (2)
Change from baseline pain score at 6 weeks
visual analog scale (VAS)- scale for patient self-reporting of pain. 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain). a lower pain level 6 weeks after surgery is a better outcome
Measured: before and 6 weeks after surgery
Change from baseline quality of life score at 6 weeks
The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. a higher score 6 weeks after surgery is a better outcome
Measured: before and 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start12 Aug 2019
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Why it stopped: slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups (treatment, control) each group is evaluated pre and post-surgery
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyal Rom, MD, HaEmek Medical Center, Israel
- Investigators
- Eyal Rom, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013126
- Sponsor's protocol ID
- 0100-18-emc
- Status last verified
- Sep 2023
- First submitted
- 4 Jul 2019
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction Among Woman With Endometriosis After Surgical Treatment
- ClinicalTrials.gov ID
- NCT04013126
- Acronym / sponsor ID
- 0100-18-emc
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment rate
- Enrolment
- 22 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Endometriosis is a chronic disease defined as an ectopic endometrial tissue outside the uterus, mostly in the pelvis. It is related to major morbidity and infertility. It is also 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". It refers to dilation (widening) of an artery when blood flow increases in that artery after An intentional block of the blood flow. 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.
The test is performed by attaching two sensors to the patient's fingertips. Using this method requires short training interval, completely user-independent and the accepted result is a quantitive index. Because it takes only 15 minute to complete the test 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, so no difference was shown between them and healthy women, 2 years thereafter.
In a large meta-analysis, evaluating 5,547 patients, every 1% improvement in the FMD scale resulted in a 13% decrease in the rate of cardio-vascular events.
In a meta-analysis evaluating 5,547 patients a 13% reduction in the risk to cardio-vascular events was demonstrated for every 1% improvement in the FMD score.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups (treatment, control) each group is evaluated pre and post-surgery
| Arm | Type | Receives |
|---|---|---|
| endometriosis | Experimental | Diagnostic Test: • Endothelial function using ENDOPAT systemWomen who undergoing surgery for removal of endometriosis implants |
| non-endometriosis | Active comparator | Diagnostic Test: • Endothelial function using ENDOPAT systemWomen who undergoing surgery for removal of benign masses in the pelvis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who undergoing surgery for removal of endometriosis implants
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| • Endothelial function using ENDOPAT systemAll 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. | Diagnostic test | endometriosis, non-endometriosis |
Primary outcome
Change from baseline endothelial function at 6 weeks
Time frame: before and 6 weeks after surgery
RHI index - "Reactive Hyperemia Index"
Change from baseline inflammatory markers at 6 weeks
Time frame: before and 6 weeks after surgery
C-reactive protein
2 secondary outcomes
Change from baseline pain score at 6 weeks
Time frame: before and 6 weeks after surgery
Change from baseline quality of life score at 6 weeks
Time frame: before and 6 weeks after surgery
Results and safety
The study was stopped early (reason given: slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Rom, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing • Endothelial function using ENDOPAT system in people with Endometriosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline endothelial function at 6 weeks (time frame: before and 6 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.