View clinical trials related to Leiomyoma.
Filter by:Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal. Research Design This study is a single-center, randomized, single-blind, 1:1 controlled trial. Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups. Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids. Control group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids. Observation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity). Secondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.
High intensity focused ultrasound ablation (HIFUA) is a new non-invasive treatment method for uterine tumors. Traditionally, nuclear magnetic resonance imaging (NMRI), also known as magnetic resonance imaging (MRI), is used as guidance to focus ultrasound on the fibroid tissue, generating high temperatures of 65-85 ℃, causing protein inactivation, cell apoptosis, and coagulation necrosis of tumor cells. While accurately ablating fibroid tissue, it avoids damaging normal tissue outside the treatment area. Since 2000, a large number of clinical studies have demonstrated the safety and effectiveness of MRI for HIFUA in the treatment of uterine fibroids. In 2013, the Chinese FDA approved MRI guided HIFUA treatment for uterine fibroids. At present, more and more medical institutions in China have introduced this device and carried out non-invasive treatment of uterine fibroids. In March 2020, the Minimally Invasive Treatment Group of the Magnetic Resonance Application Professional Committee of the China Medical Equipment Association designated the "Chinese Expert for MRI Guided Focused Ultrasound Treatment of Uterine Fibroids", making HIFUA more standardized. Superb micro vascular imaging (SMI) is an improved Doppler technology that applies a new adaptive algorithm to remove tissue motion signals and blood flow overflow phenomena, and can clearly display the extremely low velocity blood flow inside the blood vessels. Previous studies have shown that SMI has a significantly higher ability to detect blood vessels in tumors than color Doppler flow imaging (CDFI), and can more sensitively detect the blood flow of microvessels within tumors. This provides a cheap and simple non-invasive examination method for clinical practice, and real-time guidance for treatment can be provided during the treatment process, making it easy to operate and promote in clinical practice. This study randomly divided all adult patients diagnosed with uterine fibroids or adenomyosis admitted to our hospital from May 2024 to December 2024 into two groups based on the inclusion and exclusion of specimens: 1) Experimental group: HIFUA treatment, treatment efficacy evaluation using SMI technology; control group: HIFUA treatment, treatment efficacy evaluation using organ contrast-enhanced ultrasound technology. Both groups of subjects need to be followed up: at 3 months, 6 months, and 12 months after treatment, patients will undergo gynecological uterine ultrasound examination at the outpatient department, and the volume of uterine fibroids or adenomyosis will be recorded. The aim of this study is to compare the accuracy data of two groups in evaluating treatment effectiveness, and to verify that ultra-fine blood flow imaging (SMI) technology is superior to organ contrast-enhanced ultrasound in evaluating the efficacy of HIFUA treatment。
To research risk factors for recurrence of uterine fibroids and build a prediction model of recurrence of uterine fibroids to facilitate the early detection as well as the early intervention for patients who are prone to recur.
This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.
The study participants are patients with uterine fibroids and healthy physical examination subjects from the First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital). The main purpose of this study is to analyze the correlation between uterine fibroids and vaginal microecology and cervical local immune function in patients of childbearing age.
This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.
This is a single-arm clinical trial evaluating the safety and efficacy of ultrasound-guided HIFU (Sonotrip V20) for symptomatic uterine fibroids. 57 cases will be enrolled at a Korean institution. Participants will undergo the HIFU procedure based on a pre-established plan using MRI images. Assessments will be conducted immediately post-procedure and at 4 and 24 weeks. Primary endpoint is fibroid volume reduction at 24 weeks, with secondary endpoints including Non-Perfused Volume Ratio, quality of life, hemoglobin change, pain assessment, and additional medication use. Adverse events will be monitored.
Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the instrumentalization and the need of cervical dilation, the use of local anesthesia, with or without sedation, is recommended. The different alternatives described in the literature are the following: 1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix. 2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions. 3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity. 4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix. To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a prospective multicentric study that compare two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.
In 2% to 3% infertility women, myoma is the only factor relevant to their infertility. However, the effects of intramural myoma on fertility are controversial. For infertile women with intramural myoma (types IV, V, VI of FIGO system) of 4 to 6 cm diameter, it is not clear whether myomectomy could improve pregnancy outcomes, especially in women undergoing ART. Besides, rigorous clinical research is needed to explore the changes and relevant biomarkers of endometrial receptivity through multi-omics study in patients undergoing myomectomy and ART treatment. Method Intervention and follow-up: (1) For the control group, evaluation protocols such as salpingography and/or laparoscopic tubal fluxation should be implemented to identify disorders such as hydrosalpinx. (2) Imaging evaluation: all pelvic MRI were performed. Other options such as transvaginal ultrasound are not excluded, but won't replace MRI. Enhanced MRI or DWI may be considered, but are not always required. (3) Surgical intervention: laparoscopic myomectomy is preferred, and abdominal myomectomy is also acceptable. (4) IVF treatment: the IVF regimen should include detailed records of the downregulation plan, number of cycles, frozen or fresh blastocysts. Study endpoints (1) Primary study endpoint: Live birth rate after IVF. (2) Secondary study endpoints: Clinical pregnancy rate after IVF; Cumulative pregnancy rate after IVF; Biochemical pregnancy rate after IVF; Sustained pregnancy rate after IVF (≥20 weeks); Miscarriage rate after IVF; Cycles of IVF; Pregnancy-related complications; Perinatal maternal and neonatal complications. (3) Exploratory endpoints: The correlation between imaging index and assisted reproductive outcomes, including endometrial thickness, uterine volume, type of endometrial echo, uterine contraction; endometrial vascular index (VI), flow index (FI), tubular flow index (VFI); uterine artery pulsation index (PI), uterine artery resistance index (RI), systolic/diastolic blood pressure of uterine artery (S/D). The correlation between endometrial receptivity and assisted reproductive outcomes is analyzed based on transcriptomics, metabolomics, methylation and proteomics in samples from peripheral blood, endometrial biopsy, endometrial exfoliated cells, cervical exfoliated cells and myoma.
Transcervical resection of myoma(TCRM) has a good therapeutic effect while the probability of complete resection of type I and II fibroids is only 55% per procedure on average and a significant number of patients have fibroid remained.At present, there is no standardized treatment option for reducing the remaining submucous fibroids volume and preventing its recurrence after TCRM.The present prospective,multicentre,randomised controlled clinical trial will enrol women after TCRM and treat them with mifepristone(10mg)or GnRHa(3.60mg)for 3 to 6 months,investigating the effective and cost-effective treatment options after fibroids with TCRM，thus to provide evidence and effectual regiments for reducing remaining fibroids volume and preventing its recurrence.