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Leiomyoma clinical trials

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NCT ID: NCT06244251 Active, not recruiting - Uterine Fibroid Clinical Trials

Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids

Start date: June 24, 2023
Phase: N/A
Study type: Interventional

Myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or multi-port laparoscopic surgery (MPLS). Power morcellation used in MPLS was correlated with unidentified risk of tumor dissemination, especially in cases with accidental surgical findings of uterine sarcoma or leiomyosarcoma. Moreover, TU-LESS was reported to exceed MPLS in fast recovery. Therefore, the aim of this prospective cohort study is to compare the effectiveness of fast recovery and relative risk of tumor dissemination between TU-LESS and MPLS in myomectomy for the treatment of uterine fibroids.

NCT ID: NCT06114758 Active, not recruiting - Clinical trials for Postoperative Complications

Comparison Effectiveness of Rectal Misoprostol & Intravenous Tranexamic Acid Reducing Hemorrhage in Myomectomy

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

Fibroids are the most commonly encountered tumors in the female reproductive system. In patients, fibroids most often lead to abnormal uterine bleeding and the resulting anemia. In some cases, they can cause infertility or habitual abortions. Another complaint caused by fibroids is pain due to pressure and effects on adjacent organs. Very large fibroids can lead to abdominal swelling. Therefore, if a patient becomes symptomatic due to fibroids, myomectomy or, if necessary, hysterectomy is required. Because fibroids have a significant blood supply, there is a high risk of intraoperative bleeding and related complications. Additionally, the most common complication in these patients after the operation is bleeding. In many of these patients, intraoperative or postoperative blood transfusions are performed. If bleeding cannot be intervened early in these patients, hemodynamic instability, shock, coagulopathy, and, in the final stage, death can occur due to hemorrhage. Therefore, both intraoperative and postoperative bleeding control is of vital importance in patients undergoing myomectomy.

NCT ID: NCT05930769 Active, not recruiting - Myoma;Uterus Clinical Trials

Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021 (ImpactRA)

ImpactRA
Start date: June 1, 2022
Phase:
Study type: Observational

ImpactRA is an observational retrospective study. The management of the patient is not modified by this study. This study will be carried out based on the already existing data of the gynecological ward of CHU Clermont-Ferrand between 2016 and 2021. During this period of time, 17 patients have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, aided by augmented reality (AR). The investigators compared these 17 patients that underwent surgery with AR with 17 control patients that underwent the same surgery with the same indication but without AR.

NCT ID: NCT05607602 Active, not recruiting - Thrombosis Clinical Trials

Are Uterine Fibroids Pro-thrombotic?

Start date: October 17, 2022
Phase:
Study type: Observational [Patient Registry]

This study will investigate whether the presence of uterine fibroids is independently associated with a laboratory defined pro-thrombotic phenotype. VTE is associated with significant mortality and morbidity. In addition, treating patients with UF and thrombosis represents a particular challenge as fibroids frequently cause menorrhagia, which is exacerbated by anticoagulation. It is therefore important to recognise and detect risk factors and prevent thrombosis wherever possible. If a pro-thrombotic phenotype is detected in patients with UF as their sole risk factor, then this could justify a new approach to the assessment and risk-management of a very large number of patients and could translate into a reduction in both morbidity and mortality for affected patients.

NCT ID: NCT05505331 Active, not recruiting - Clinical trials for Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping

Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross Sectional Observational Study

Start date: August 15, 2022
Phase:
Study type: Observational [Patient Registry]

Three-Dimensional Ultrasonography versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross sectional Observational study

NCT ID: NCT05445167 Active, not recruiting - Clinical trials for Uterine Fibroids (MeSH Heading: Leiomyoma)

A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain

NCT ID: NCT05440383 Active, not recruiting - Clinical trials for Uterine Fibroids (MeSH Heading: Leiomyoma)

A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Start date: October 11, 2022
Phase: Phase 3
Study type: Interventional

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

NCT ID: NCT05091697 Active, not recruiting - Fibromyoma;Cervix Clinical Trials

Cost-utility of VIRTUAL FIBROWALK

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

The main objective of this study is to assess the effectiveness and cost-utility of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as- usual (TAU) compared to TAU alone.

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: 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.