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Targeted vessel ablation of type 3 uterine fibroids with magnetic resonance guided high intensity focused ultrasound

To investigate whether it is possible to manipulate perfusion in type 3 fibroids with MR-HIFU.

Validation study of a novel clinical algorithm in evaluating abnormal uterine bleeding using a Combination of Saline Infusion Sonohysterography (SIS) and endometrial brush biopsy (EMB).

Primary Objective: To assess whether the combination of Saline Infusion Sonohysterography (SIS) and Endometrial Brush Biopsy (EMB) will create an innovative algorithm for diagnosing corpus uteri malignancy in postmenopausal women suffering from…

Laparoscopic advanced Imaging Techniques in Endometriosis therapy: the LITE study. A pilot trial.

To determine which advanced image enhanced modality is the most feasible for the detection of endometriosis lesions, with respect to the specificity and sensitivity of the investigated modalities. To determine which imaging modality reveals more…

An open-label, multiple-dose, sequential, 2 treatment period study to evaluate the effect of QBW251 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in pre-menopausal healthy female volunteers

- To assess the effect of QBW251 on the pharmacokinetics of a monophasic combined oral contraceptive containing 30 µg ethinyl estradiol (EE) and 150 µg levonorgestrel (LVG).- To assess the effect of QBW251 on the pharmacodynamics of a monophasic…

RCT comparing insertion of levonorgestrel releasing intrauterine system (Mirena) during the menstruation compared with random insertion beyond menstruations in patient-perceived pain.

In this randomized study, timing during (day 1-7 of the menstruation cycle WITH vaginal blood loss) or beyond menstruation (in menstruation cycle day 8 and further WITHOUT vaginal blood loss) will be compared regarding differences in patient-…

A prospective, multicenter clinical trial to evaluate the safety and the effectiveness of the AEGEA Vapor System* for the treatment of excessive uterine bleeding.

To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities

- To establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in NGM/EE Schaffhausen tablets compared with the same hormones in NGM/EE Manati tablets.- To assess the safety and tolerability of both…

Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids

The objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.

Magnetic Resonance Imaging to diagnose endometriosis using Ablavar ®
as contrast agent - a feasibility study

Primary Objective: test the feasibility of Dynamic-CE-MRI using Ablavar ® as contrast agent to detect peritoneal endometriosis in women.Secondary Objective(s): # To assess the image quality of Ablavar ®-enhanced MRI in comparison to unenhanced MRI…

Hysteroscopic resection of uterine scar defects (niche) in patients with abnormal bleeding, a randomised controlled trial

Our primary objective is to study the effectiveness of hysteroscopic resection for niche related uterine bleeding disorders. The procedure will be performed in small niches with a residual myometrium of more than 3mm.Our secondary objective is to…

A RANDOMISED CONTROLLED TRIAL COMPARING BALLOON ENDOMETRIAL ABLATION (THERMABLATE) VERSUS BIPOLAR ENDOMETRIAL ABLATION (NOVASURE) IN THE OUTPATIENT CLINIC WITH LOCAL ANESTHESIA

The purpose of the study is to evaluate the effectiveness and acceptability of the hot fluid balloon endometrial Thermablate ablation system compared with the Bipolar RF Novasure ablation treatment performed in an outpatient setting in eliminating…

An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device (D-UAO) as Treatment for the Reduction of Fibroid-Associated Symptoms

The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms. 

Pilotstudy on effect of hysteroscopic resection treatment of patients with abnormal uterine bleeding and a scardefect after a cesarean section

To study if a hysteroscopic resection a safe and effective treatment is for intermittend/post menstrual bloodloss or spotting.

Scar Evaluation after Caesarean by Ultrasound Registry

Ultrasonography shows a niche at the site of the uterine caesarean scar in the majority of women with a CS in the past history. A niche is a triangular, anechoic area at the presumed site of incision. Our primary objective is to develop an…

Nociceptive and stress hormonal state during hysterectomy as an index of pain perception: a prospective study.

This study primarily aims to get insight in the intraoperative nociceptive state of the patient as an index of the amount of pain stimuli comparing the three modes of hysterectomy. Next to this, by measuring pre-, intra- and postoperative stress…

A randomized, parallel-group, double-blind placebo-controlled and open label active-controlled, multi-center study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids

The primary objective of this study is• To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are• To assess the efficacy of vilaprisan in subjects with uterine fibroids…

Evaluation of the Gynesonics System for Transcervical Treatment of Symptomatic Uterine Fibroids with Radiofrequency Ablation under Integrated Intrauterine Sonography Guidance

To establish the safety and effectiveness of the Sonata System in the treatment of symptomatic uterine fibroids.

Endometriosis diagnostics-Fusion MRI-ultrasound

To determine the feasibility of Fusion MRI-ultrasound for the uterus and ovary.To determine if Fusion MRI-ultrasound is more accurate for the diagnosis of endometiosis then MRI or ultrasound alone.

Procedural sedation for hysteroscopic myomectomy: cost effectiveness

Is hysteroscopic resection of submucous myomas under procedural sedation with propofol (PSA) in an outpatient setting a cost-effective alternative for hysteroscopic myomectomy performed under general anesthesia in the operation room?

SAFE: Sequre for Adenomyosis and Fibroid Embolisation

The aim of this research is to test the efficacy and safety of a new microcatheter 2.8F Sequre for treatment of uterine fibroids and/or adenomyosis with a standard embolization technique and to demonstrate the added value of this catheter, namely to…