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Leiomyoma clinical trials

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NCT ID: NCT04960293 Not yet recruiting - Clinical trials for Symptomatic Uterine Fibroids

Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids

Start date: July 2021
Phase: N/A
Study type: Interventional

The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids

NCT ID: NCT04935333 Recruiting - Leiomyoma, Uterine Clinical Trials

Accuracy of the Preoperative Molecular Diagnosis of Uterine Tumors by Liquid Biopsy

MYOSARCII
Start date: September 2021
Phase:
Study type: Observational

The development of precise and non-invasive diagnostic methods is a priority in areas such as gynaecology and oncology, and above all in improving the health of those patients with a surgical indication for hysterectomy, laparoscopic or laparotomic myomectomy for diagnosis of uterine tumours. Indeed, in the absence of an accurate and objective preoperative diagnostic option, all patients with suspected benign tumours should be considered at risk for occult leiomyosarcoma. Recently, the concept of "liquid biopsy" has emerged as a minimally invasive alternative to surgical biopsies for solid tumours with highly recurrent mutations, avoiding the sampling of tumour tissue before and after treatment. Generally, the liquid biopsy is obtained by taking a sample of blood or other body fluids, to provide tumour-specific information. Based on these premises, a prospective, observational and multicentre case-control study is proposed, the objective of which is to evaluate the diagnostic precision (sensitivity, specificity, negative predictive value and positive predictive value) in the detection of molecular differences by liquid biopsy in patients with suspected myometrial tumour (leiomyoma / leiomyosarcoma). Depending on the results of these analysis, the application of this technology could allow the differential diagnosis of the tumour in a non-invasive and objective way, as well as the development of biomarkers and effective targeted therapies in the treatment of leiomyosarcomas. Consequently, we would also be increasing our knowledge of tumour biology and associated pathologies in a clinical and therapeutic context.

NCT ID: NCT04874246 Completed - Uterine Leiomyoma Clinical Trials

Comparison of Concentration of Vasopressin During Robot-assisted Laparoscopic Myomectomy

VALENTINE
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effect of the concentration of vasopressin, which is used as a method for reducing blood loss in robot-assisted laparoscopic myomectomy.

NCT ID: NCT04856306 Active, not recruiting - Clinical trials for Heavy Menstrual Bleeding

Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L

Magical
Start date: April 12, 2021
Phase:
Study type: Observational

This is a prospective cohort study comparing the novel FDA-approved oral GnRH antagonist ORIAHNN (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) to uterine artery embolization (UAE) or myomectomy (abdominal, laparoscopic, or hysteroscopic) for treatment of heavy menstrual bleeding due to leiomyomas. Uterine leiomyomas, also called fibroids, are hormone-dependent growths in the uterine muscle that are common in reproductive-age women (1). Leiomyomas can often lead to heavy menstrual bleeding. Definitive treatment for abnormal uterine bleeding due to leiomyomas is hysterectomy, but for patients who desire uterine conservation, a variety of treatment options exist. Regulation of menses with combined oral contraceptives or progestin only oral formulations are generally considered first line treatment but are not curative or effective for many patients. Another treatment option is a myomectomy, which is the surgical resection or removal of myomas. Myomectomy can be performed via hysteroscopy or laparoscopy, or by a vaginal or an abdominal approach. The route of removal depends on myoma location and patient symptoms. Another treatment option is Uterine fibroid or uterine artery embolization (UFE/UAE). UAE is a minimally invasive procedure where permanent particles are delivered to and block/embolize the blood supply to the myoma via a fluoroscopy directed arterial catheter. This typically leads to a decrease in fibroid size and associated bleeding (2). ORIAHNN, an oral GnRH antagonist that was FDA-approved in 2020, has demonstrated significant decrease in myoma-associated heavy menstrual bleeding compared to placebo (1) but has not been compared to other standard of care interventions. The primary objective of this study is to compare this novel medication to the common AUB-L treatments UAE and Myomectomy.

NCT ID: NCT04849858 Recruiting - Ovarian Cancer Clinical Trials

Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures

Start date: May 20, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

NCT ID: NCT04832906 Completed - Uterine Fibroid Clinical Trials

UA Versus UAE in Treatment of Fibroids

Start date: March 13, 2019
Phase: Phase 4
Study type: Interventional

Study objective: To prove that Ulipristal acetate is an effective line of management for uterine fibroids by causing a significant decline in fibroid volumes resulting in a substantial relief of fibroid-related symptoms, and to compare its results with those of uterine artery embolization. Design: A randomized control trial. Setting: Maternity Hospital, Ain Shams University. Patients: Women with symptomatic uterine fibroids. Interventions: 70 women were randomly assigned to either Ulipristal Acetate (UA) group or uterine artery embolization (UAE) group (35 in each group). Both groups were followed up to detect the decline in fibroid size as well as the improvement of symptoms.

NCT ID: NCT04819633 Completed - Uterine Leiomyoma Clinical Trials

Evaluating Serum Sestrin in Leiomyoma Patients

Start date: January 1, 2021
Phase:
Study type: Observational

Leiomyomas are the most common benign neoplasms of women's reproductive system affecting 20-30% of women within the reproductive ages. Sestrins are serum proteins which are highly expressed under circumstances of DNA damage, hypoxia and oxditive stress and play an important role in autophagia. The aim of this study is to evaluate the relationship of serum sestrin proteins with development of leiomyomas.

NCT ID: NCT04762316 Completed - Clinical trials for Uterine Fibroids Affecting Pregnancy

Composition for Treating Uterine Fibroid (PP6)

PP6
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Pregnenolone & Pyridoxal Phosphate (PP6) for treating uterine fibroids in women pregnancy to lost the size fibroids and to dissolve fibroids. Uterine fibroids are a very common finding in women pregnancy of reproductive age, fibroids fast grow in the first trimester pregnancy. PP6 against the rapid growth of fibroids under the influence of hormones during pregnancy. Use to PP6 think about regulating stable Oestrogen level and to dissolve fibroids. This is a substantial insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance and perfect in management or public health policy.

NCT ID: NCT04756037 Active, not recruiting - Contraception Clinical Trials

Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

SERENE
Start date: March 18, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the contraceptive efficacy of relugolix combination therapy.

NCT ID: NCT04748978 Recruiting - Uterine Fibroid Clinical Trials

OPPIuM Technique and Myolysis With Diode Laser Dwls

Myolysis
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

PURPOSE OF THE STUDY The study aims to examine the feasibility and effectiveness of the OPPIuM technique combined with myolysis using the DWLS diode laser. In addition, to evaluate the reduction of myoma volume and the extent of uterine bleeding with myolysis to improve women's quality of life and avoid resectoscope hysteroscopy for a G2 MIOMA, which may lead to an increase in intraoperative surgical risks and long-term complications. POPULATION 35 patients aged between 18 and 48 years with clinical and/or ultrasound diagnosis of uterine fibromatosis, belonging to the Endometriosis/Pelvic Chronic Pain Centre of the Complex Operating Unit of Gynecology of the University Polyclinic of Monserrato and other centers involved in the study. To be eligible for inclusion, patients with ultrasound and hysteroscopic diagnosis of a single submucosal myoma, partially intramural (G1 or G2) ≤ 3 cm, must present symptoms such as abnormal uterine bleeding and pelvic pain, for which surgical treatment was scheduled. INCLUSION CRITERIA - Women between 18 and 48 years old - Diagnosis of symptomatic uterine fibromatosis (abnormal uterine bleeding and/or pelvic pain) with single fibroma ≤ 3 cm G1 or G2. EXCLUSION CRITERIA Patients who cannot provide written informed consent or follow the procedures set out in the protocol. - Patients with malignant neoplasms or serious systemic diseases - Patients with multiple fibroids or single > 3 cm - Asymptomatic patients - Patients with other uterine or related diseases - Patients seeking a pregnancy. INTERVENTION STRATEGY AND INSTRUMENTS A total of 35 women will initially be included in the study, of which: Patients will undergo the following assessments: - Collection of physiological, pathological, and pharmacological anamnesis - Collection of diagnostic tests (ultrasound) and staging of the underlying disease (uterine fibromatosis) - Completion of the PBAC questionnaire - Transvaginal ultrasound - Office diagnostic hysteroscopy with OPPIuM and Myolysis - Possible resectoscope hysteroscopy or laser myomectomy in narcosis.