Phase II Study of the Da Vinci Single Port (SP) Robotic System for Abdominal and Pelvic Procedures

City of Hope Medical Center1 个研究点分布在 1 个国家目标入组 33 人2024年4月26日

适应症Disease or Disorder

干预措施Robot-Assisted Surgery

概览

阶段: 2 期
干预措施: Robot-Assisted Surgery
疾病 / 适应症: Disease or Disorder
发起方: City of Hope Medical Center
入组人数: 33
试验地点: 1
主要终点: Incidence of major surgical complications
状态: 招募中
最后更新: 12天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port [SP]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

详细描述

PRIMARY OBJECTIVE: I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures. OUTLINE: Patients undergo surgery using the da Vinci SP1098 robotic system on study.

注册库

clinicaltrials.gov

开始日期

2024年4月26日

结束日期

2026年10月13日

最后更新

12天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

City of Hope Medical Center

责任方

Sponsor

入排标准

入选标准

•Documented informed consent of the participant and/or legally authorized representative
•Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures
•Age \> 18 years

排除标准

•Body mass index (BMI) \> 45
•Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders
•Past history of failed attempt of minimally invasive abdominal or pelvic surgery