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Leiomyoma clinical trials

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NCT ID: NCT04482959 Completed - Myoma;Uterus Clinical Trials

Intraoperative Carbetocin to Decrease Blood Loss During Hysteroscopic Myomectomy

Start date: July 15, 2020
Phase: Phase 4
Study type: Interventional

Submucous myomas represent one of the main indications of operative hysteroscopy. Since 1976 when Neuwirth and Amin reported the first five cases of excision of submucous myomas , several techniques have been developed in order to render hysteroscopic myomectomy a safe and effective procedure . Hysteroscopic myomectomy is currently considered the "gold standard" minimally invasive approach for the treatment of symptomatic submucous myomas . Patients undergoing hysteroscopic myomectomy are liable to significant blood loss, and hemodynamic and hematological disturbances. Excessive bleeding during hysteroscopic myomectomy remains a major challenge for the endoscopic gynecological surgeons. Many interventions were introduced to reduce the risk of bleeding during myomectomy. These include the use of utero-tonics such as oxytocin, or the use of anti-fibrinolytics such as tranexamic acid . The potential advantage of oxytocin infusion during hysteroscopic myomectomy is that it can maintains uterine contractility throughout the procedure, and thus, reduce blood loss . Carbetocin (1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic agonist analogue of the human oxytocin. When injected to a woman, it induces uterine contractions . Although many interventions have been described to reduce the intraoperative blood loss during hysteroscopic myomectomy, there is a need for a well-designed randomized controlled trials to identify the most efficient interventions, with reasonable safety profiles, to help the perform a safe and curative surgery.

NCT ID: NCT04345003 Completed - Uterine Fibroid Clinical Trials

MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids

ELASTUS
Start date: June 18, 2020
Phase: N/A
Study type: Interventional

Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU

NCT ID: NCT04279626 Completed - Uterine Myoma Clinical Trials

Surgical Outcome of Two-port Laparoscopic Myomectomy

Start date: January 21, 2015
Phase:
Study type: Observational

Study Objective: To evaluate the surgical outcome of laparoendoscopic two-sites myomectomy (LETS-M) and compare the difference between an experienced surgeon and three trainees. Design: A retrospective study. Setting: A university hospital and a tertiary care center. Patients: 204 women underwent LETS-M

NCT ID: NCT04272216 Completed - Clinical trials for Benign Prostatic Hyperplasia

An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

RAVI Registry
Start date: February 6, 2020
Phase:
Study type: Observational [Patient Registry]

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.

NCT ID: NCT04177693 Completed - Uterine Fibroids Clinical Trials

Pharmacokinetics and Hepatic Safety of EGCG

Start date: November 24, 2020
Phase: Phase 1
Study type: Interventional

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

NCT ID: NCT04091529 Completed - Uterine Fibroids Clinical Trials

Tailored Radiofrequency Ablation of Uterine Myomas

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

To perform the use of radiofrequency myolysis (RFM) for the treatment of intra-uterine fibroids through less invasive access by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy

NCT ID: NCT04030182 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D Deficit in Women With Uterine Fibroids

Start date: December 1, 2019
Phase:
Study type: Observational

Determinate the level of vitamin D in blood, and evaluate the prevalence of deficit and insufficiency among patients with diagnosis of uterine fibroids

NCT ID: NCT03989661 Completed - Uterine Fibroid Clinical Trials

Is There a Place for Pre-operative Temporary Embolization of Uterine Fibroids

EMBOFIB
Start date: July 12, 2019
Phase:
Study type: Observational

Uterine fibroids are the most common benign tumors of the female genital tract, with an estimated incidence of 25-80% during the reproductive period in the general population. If the affected patients do not usually have any symptoms, uterine fibroids may also, depending on their location, be responsible for acute and chronic pelvic pain, bleeding and infertility. Symptomatic uterine fibroids are now treated in the first line by surgery (hysterectomy, laparotomy myomectomy, laparoscopy or hysteroscopy). When conservative treatment is indicated and the fibroid is not hysteroscopically accessible, myomectomy can be performed by laparotomy or laparoscopy. Excision of myomas often richly vascularized exposes the surgeon and the patient to a risk of bleeding per- and / or post-operative sometimes severe, resulting in an increase in operating times, an increased risk of postoperative complications and need transfusion. The literature is rather poor on this subject but some factors favoring bleeding have been identified: the history of myomectomy, a uterine volume equivalent to more than 20 weeks of amenorrhea, the excision of more than 10 fibroids, or an incisional approach. In order to reduce these intraoperative bleeds, numerous therapeutic strategies have been developed, using drug alternatives (GnRH agonists, Ullipristal) or interventional radiology (embolisation of the uterine arteries). The improvement of interdisciplinary collaboration is now seeing the emergence of numerous therapeutic strategies combined. The effectiveness of uterine artery embolization has been demonstrated for several years in the treatment of fibroids, alone or in combination with surgical myomectomy. Some studies on preoperative embolization (maximum 24 hours before the intervention) have shown encouraging results with regard to the volume of bleeding, the need for per or post-operative transfusion or the need for surgical revision, or even decision to hystérectomie. In 2011, Butori et al. propose the use of absorbable spongy particles (Curaspon type) for preoperative embolization. The use of these resorbable particles would reduce the risk of postoperative synechia. Some studies indicate that embolization of the uterine arteries using non-absorbable material would be responsible for ovarian failure by hypo-infusion. The use of absorbable material would avoid this adverse effect while preserving its effectiveness for the surgical procedure, but to date no study clearly demonstrates this. This retrospective case-control study aims to compare the occurrence of per-and post-operative adverse effects between a test group consisting of patients who had undergone preoperative embolization (with resorbable material) before myomectomy (intervention group) and a control group with myomectomy without embolization (control group).

NCT ID: NCT03985449 Completed - Uterine Fibroid Clinical Trials

Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings

UPFRONT
Start date: August 1, 2019
Phase: N/A
Study type: Interventional

UPFRONT is a study that aims to use two implementation frameworks - the Consolidated Framework for Implementation Research and the Normalization Process Theory - to guide the implementation of a uterine fibroid patient decision aid, known as Option Grid, at five diverse gynecology settings across the United States. Option Grid provides evidence-based information on the various treatment options to help women across socioeconomic strata with symptomatic uterine fibroids make a preference-sensitive decision.

NCT ID: NCT03972917 Completed - Dysmenorrhea Clinical Trials

Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy

Start date: November 1, 2018
Phase:
Study type: Observational

A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.