Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Thrombosis

Venous Thrombosis

Hemorrhage

Varicocele

Endoleak

Angiomyolipoma

Embolism

Embolism and Thrombosis

Vascular Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Aneurysm

Postoperative Hemorrhage

Postoperative Complications

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Perivascular Epithelioid Cell Neoplasms

Patients requiring embolization of varicocele, portal vein before ablation, type 2 endoleak, angiomyolipoma or active bleeding will be treated with the liquid embolic agent Easyx during index procedure.

Embolization will be done with Easyx liquid agent.

Easyx

Marc SAPOVAL, MD, PhD

Romaric LOFFROY, MD, PhD

Vincent VIDAL, MD, PhD

The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (\<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).

French multicenter, phase 2b (device), prospective study

EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

Expected and unexpected per-procedure (SAE) related to the EASYX™ use (imputability "certain" or "probable")

Percentage of clinical success. The clinical success of type II endoleaks embolization is defined as the stability or reduction of aneurysm's both anterioposterior and transverse diameters assessed on CT-scan at 6 months compared to baseline (4mm threshold).

Percentage of clinical success before ablation for portal vein embolization. The clinical success of portal vein embolization is defined as the growth ≥15 % of the remnant liver assessed on presurgical CT-scan compared to baseline

Percentage of clinical success for varicocele embolization The clinical success of varicocele embolization is defined as the absence of reflux on ultrasound Doppler at one month follow-up.

Percentage of clinical success for angiomyolipoma embolization. The clinical success of angiomyolipoma embolization is defined as the reduction \>10% of at least one diameter on MRI or CT-scan at 3 months follow-up compared to baseline

Percentage of clinical success for active bleeding embolization The clinical success of active bleeding embolization is defined as the complete occlusion of the target vessel assessed by angiography during the index procedure

Total number of unanticipated ischemia of the target organ

Total number of secondary post-embolization orchi-epididymitis (varicocele embolization)

Total number of neural root lesion (type II endoleaks)

Total number of aneurysm rupture (type II endoleaks)

Total number of tumor rupture (angiomyolipoma)

Use of Visual Analog Scale (VAS) to evaluate the pain at device injection (between 0: no pain to 10: intolerable pain)

Use of Visual Analog Scale (VAS) to evaluate the painful varicocele (between 0: no pain to 10: intolerable pain)

Total number of unanticipated use of another liquid agent for embolization

Total number of procedures with immediate technical success

Mean volume of EASYX™ used during the index procedure

Mean degree of occlusion of the target vessel(s)

Total number of re-intervention for study procedure

Immediate technical satisfaction questionnaire (as perceived by the Interventional Radiologist)

Total number of embolization clinical efficacy

Total number of procedures with a need to complete with another liquid embolic to achieve optimal result

Technical success at follow-up assessed on CT-scan for type II endoleaks defined as the ability for the physician to give a diagnosis (absence or minor artifacts) on imaging

Antia Therapeutics AG

Assistance Publique - Hôpitaux de Paris

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Testicular Neoplasms

Spermatic Cord Torsion

Testicular Hydrocele

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Quality of Life

All Drugs and Chemicals

Androgens

Hormones

Follicle Stimulating Hormone

Patients treated for testicular cancer, will receive questionnaires and hormonal function measurement.

Patients treated for benign testicular conditions, will receive questionnaires and hormonal function measurement.

Healthy volunteers, will receive questionnaires and hormonal function measurement.

Questionnaires:

For examinee: European Organization for Research and Treatment of Cancer quality of life questionnaire of 30 items and testicular cancer module of 26 items (EORTC QLQ-30 + QLQ-TC-26), Multidimensional Coping Inventory, The Meaning Test for cognitive function, cognitive orientation questionnaires.

For partner: Multidimensional Inventory of quality of life (QoL) for Adults, Multidimensional Coping Inventory.

Questionnaires

Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.

Hormonal Function measurement

David Margel, MD PhD

Chen G Shenhar, MD

David Margel, MD Phd

Testicular Cancer is the most prevalent malignancy among men between 20 and 34 years of age, with incidence rates rising in western countries including Israel. Cure rate of testicular cancer exceeds 90% with modern treatments. Thus issues such as quality of life (QoL), coping, effects on couple relationships, cognitive function, cognitive orientation and hormonal function become increasingly important. This study aims to assess all these issues using validated, reproducible questionnaires and hormonal plasma levels, and compare them between testicular cancer survivors and controls.

The study will be conducted in RMC, Beilinson and Golda. Eligible male patient list will be drawn from the Rabin Medical Center (RMC) operation rooms' data system.

Patients will be contacted by their treating urologists over the phone or during follow-up visits and invited to take part in the research which will be conducted at RMC. The first stage of the study will include a validation of the EORTC QLQ-TC26 questionnaire in Hebrew.

Patients and partners / spouses will sign informed-consent forms and fill out questionnaires during their visit, and blood samples will be drawn on the day of questionnaire completion or no longer than 1 month from it. Spouses will be given the choice of arriving with the patient and filling-in their questionnaires at RMC, or having them mailed to their homes. Research assistants will provide assistance with the questionnaires.

Normal controls will be recruited among Tel Aviv University students, 'Achva' College students and RMS staff and asked to come to RMC for blood tests. Control subjects will be asked to answer the same cancer-related questionnaires as the patients, as fully as possible, unless the questions are irrelevant to them.

The anticipated recruitment period will be approximately 36 months. Financial incentives: a compensation of 150 NIS will be offered to healthy participants coming to RMC for blood tests under this study.

Duration of research participation: 1 or 2 encounters (the second for missing data or missing blood samples, and in the first 30 patients - for TC26 questionnaire re-validation by the EORTC requirements), during no longer than 1 month for each participant.

Measurements will be compared across the patient and 2 control groups and their correlation to hormonal function assessed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications	NCT03477149	Varicocele Endoleak Portal Vein Thr... Bleeding Angiomyolipoma	Easyx	18 Years -	Assistance Publique - Hôpitaux de Paris
EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications	NCT03477149	Varicocele Endoleak Portal Vein Thr... Bleeding Angiomyolipoma	Easyx	18 Years -	Assistance Publique - Hôpitaux de Paris
Quality of Life Among Testicular Cancer Survivors	NCT02304575	Testicular Neop... Spermatic Cord ... Varicocele Testicular Hydr...	Questionnaires Hormonal Functi...	18 Years - 75 Years	Rabin Medical Center
Quality of Life Among Testicular Cancer Survivors	NCT02304575	Testicular Neop... Spermatic Cord ... Varicocele Testicular Hydr...	Questionnaires Hormonal Functi...	18 Years - 75 Years	Rabin Medical Center

Spots Global Cancer Trial Database for varicocele

Every month we try and update this database with for varicocele cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for varicocele

Every month we try and update this database with for varicocele cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for varicocele cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.