Ultrasound-guided transvaginal radiofrequency ablation of uterine fibroids performance evaluation of GYIDE
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- The main aim of this study is to evaluate the device ability to ablate the fibroid while avoiding damage to serosa or surrounding organs.
研究概览
简要总结
Uterine fibroids(leiomyomas) are common benign tumors, with a higher prevalence in women who are aged between 35 to 50 years, although some women may develop fibroids at a younger age. They can cause abnormal uterine bleeding, pelvic pressure, bowel dysfunction, frequent urination and urgency, urinary retention, low back pain, constipation, and dyspareunia. Normally, 2D ultrasound images are used to diagnose fibroids.
Ultrasonography(US)-guided transvaginal (TVS) radiofrequency ablation (RFA) in the treatment of fibroids that can be performed without the need for any abdominal cut or multiple incisions like that of existing laparotomy and laparoscopy procedures. Placement of Radiofrequency ablation (RFA) electrodes into the fibroid under ultrasound guidance and manually maneuvering to all the locations is an extremely skilled procedure. Further, there is no guidance/reference for the force required in piercing the fibroid with the RFA electrode since the texture of fibroids differs significantly. Another important aspect is fibroid Mapping: Identifying the exact location and volume of the fibroid with ultrasound images is often a challenge. Thus there are challenges in treating the fibroid just with the radiofrequency electrode and existing 2D ultrasound images This has been effectively addressed by the planning system and navigation arm by Nesa MedTech, through GYIDE.
The purpose of this study is to assess the performance of the GYIDE device that helps in processing diagnostic ultrasound imaging to provide planning and positional guidance for transvaginal approach for delivering radiofrequency ablation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women in reproductive age who have completed family planning with symptomatic uterine fibroid (menorrhagia, heavy menstrual bleeding) for at least 2 months and as confirmed by USG.
- •2.Patients presenting with 1-4 fibroids of FIGO types 2, 3, 4, and/or type 2-5, with diameter of 1.0 cm and up-to 6.0 cm.
- •3.No desire for future fertility 4.Women willing to provide informed consent for participation in the study and willing to undergo this RFA using (GYIDE) and adhere to follow-up requirements.
排除标准
- •1.Presence of a single polyp less than 1.5 cm, or multiple polyps of any size, within the uterine cavity.
- •2.Any abnormality of the endometrial cavity that obstructs access of the handpiece 3.Total uterine volume more than 1000 cc.
- •4.Pregnancy.
- •5.Presence of type 0 fibroids, unless greater than 1 cm in diameter.
- •6.Presence of an extrauterine pelvic mass that has not been diagnosed as benign.
- •7.Multiple uterine scars.
- •8.Congenital uterine abnormality 9.Previous procedure for fibroids or heavy menstrual bleeding other than myomectomy (example: endometrial ablation).
- •10.Confirmed abdominal or pelvic malignancy within the previous five years 11.Active pelvic infection or current positive testing for pelvic gonorrhea or chlamydia, UTI.
结局指标
主要结局
The main aim of this study is to evaluate the device ability to ablate the fibroid while avoiding damage to serosa or surrounding organs.
时间窗: 1.To capture the serosa in the hysterectomized specimens(visit 1- day of procedure). | 2.To evaluate the ablated region of target fibroid(visit 1- day of procedure).
次要结局
- To determine the total time required for GYIDE procedure(To record the time for mapping of fibroids(visit 1- day of procedure).)
研究者
Dr Gopinath P M
Kauvery Hospital