跳至主要内容
临床试验/CTRI/2024/09/073766
CTRI/2024/09/073766招募中不适用

Evaluating the performance of FMRA for Uterine Fibroid Mapping

Nesa MedTech Pvt Ltd5 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年9月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
156
试验地点
5
主要终点
To understand FMRA usability related challenges

研究概览

简要总结

Uterine fibroids(leiomyomas) are common benign tumors, with a higher prevalence in the reproductive age group of women, 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.

2D ultrasound images are used to diagnose fibroids routinely, however, identifying the exact location and volume of the fibroid with ultrasound images is often a challenge. This has been effectively addressed by the planning system named FMRA developed by Nesa MedTech Pvt.Ltd. FMRA post-processes 2D ultrasound images to a 3D rendered uterus model. Also, in the past FMRA has demonstrated strong positive correlation and excellent agreement with MRI in mapping of uterine fibroids, with minimal absolute variations.

Thus, the current study targets to assess any real-world challenges in using FMRA software for mapping fibroids and also how the 3D-model can help improve informed-decision making.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Women aged 21 and above diagnosed with symptomatic uterine fibroids and/scheduled for transvaginal imaging evaluation.
  • Women willing to provide written informed consent for utilizing related information.

排除标准

  • Women in whom TVS cannot be done due to severe vaginismus/ vaginal stenosis.
  • Women with endometrial polyps.
  • Women with uterus size of above to 15cm.
  • FIGO classification type 0 and type
  • Women who are pregnant.
  • Unmarried women.

结局指标

主要结局

To understand FMRA usability related challenges

时间窗: 3 months

次要结局

  • To assess the usability of FMRA in clinical decision support, through questionnaire and 3D model generated from FMRA.(3 months)

研究者

发起方
Nesa MedTech Pvt Ltd
申办方类型
Other [Medical Device Manufacturer]
责任方
Principal Investigator
主要研究者

Dr Mahesh Gupta

Puspam Upvan Prasutigruh Hospital

研究点 (5)

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