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临床试验/NCT03164850
NCT03164850已完成不适用

Laparoscopic Tactile Imaging in Urogynecologic Surgery

Advanced Tactile Imaging, Inc.1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2016年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Imaging Performance (resolution in mm)

研究概览

简要总结

During laparoscopic surgery, video camera becomes a surgeon's eyes since the surgeon uses image from the video camera positioned inside the patient's body to perform the procedure. The greatest limitation is the impairment or complete lack of tactile sensation normally used to assist in surgical dissection and decision making. The Investigator proposes to develop a tactile sensing system, Laparoscopic Tactile Imager (LTI), to be used in urogynecological laparoscopic surgery for tactile imaging and tissue characterization (elasticity, structure, boundaries, blood vessel detection) which will be imposed on the video image at area of interest in real time.

详细描述

For this study, the investigator identified the sacrocolpopexy as the target procedure for the evaluation of LTI. In the cases of sacrocolpopexy, often performed in conjunction with a hysterectomy, one of the most frustrating elements is the lack of tactile feedback at the level of the sacral promontory. The surgeon needs to open up the peritoneum and dissect the underlying tissue to expose the sacral bony structures and ligament without injury to the surrounding bowel, ureter or vascular structures. Sometimes, the sacral promontory is covered with a fat pad which makes it difficult to visualize the promontory and the "safe" space below the aorta and between the iliac arteries/veins is difficult to discern. A difference that is very easy to appreciate with an open procedure where one can easily palpate through the fatty tissues. That step is very critical for the repair and has the greatest potential for catastrophic error without tactile sensation. Because of the reproducibility of the surgical technique and target anatomy for this portion of the procedure, it was thought the sacral promontory dissection to identify and clear the anterior longitudinal ligament would be appropriate surgical procedure to evaluate the use of LTI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Stage 2 or greater pelvic organ prolapse;
  • Scheduled pelvic floor surgery.

排除标准

  • Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
  • Ongoing or prior radiation therapy for abdominal or pelvic cancer;
  • Recent (less than four months) pelvic surgery;
  • Surgically absent rectum or bladder;
  • Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
  • Severe abdominal or pelvic adhesions preventing access to pertinent anatomy;
  • Known or suspected bleeding disorder.

结局指标

主要结局

Imaging Performance (resolution in mm)

时间窗: up to 24 weeks

The LTI will restore the missing dimension during laparoscopic surgery - the real time 'sense of touch' for tissues and organs of interest. Imaging resolution is a key parameter for the outcome.

Soft tissue elasticity measurement (Pa)

时间窗: up to 24 weeks

LTI allows acquisition of stress+strain data to calculate direct tissue elasticity in Pa.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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