A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SIRIUS Endoscope Articulated tip assessment.
研究概览
简要总结
Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction.
A Prospective Study to Evaluate the Clinical Performance and Safety of the SIRIUS Endoscope System in Laparoscopic Gynecological Surgery.
The study is a single-arm prospective study to evaluate the Performance and Safety of the SIRIUS Endoscope System.
详细描述
Minimally invasive surgery (MIS) is well established in gynecological surgery. Compared to laparotomy, MIS is associated with reduced morbidity and quicker recovery. With advancement in laparoscopic technology and techniques, MIS in gynecology has progressed from multi-port to single incision laparoscopic surgery (SILS) and vaginal natural orifice transluminal endoscopic surgery (vNOTEs), thus further reducing morbidity and enhancing recovery.
One of the challenges of MIS is the restriction of the range of surgical movement. To overcome these technical challenges, articulated instruments are increasingly being used. The SIRIUS Endoscope System is a new, fully integrated compact 3D laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. The articulated tip has three degrees of freedom, enabling C and S-shaped bending, and providing a wider field of view compared to conventional laparoscopes. This wider field of view is of advantage for SILS and vNOTEs. Presently available commercial systems do not have the same field of view or degrees of freedom.
A first in-human, proof of concept, and early development study of the SIRIUS Endoscope System was done at GHK in 2021 (HKU-GHK IRB 2021-01, ClinicalTrials.gov NCT05048407). The successful completion of 11 of 13 (85%) planned procedures in this sequentially reported, prospective case series, shows that the SIRIUS Endoscope System can be used with indications of safety, and efficacy for intermediate and major MIS laparoscopic procedures in gynecology. The findings have been submitted for consideration for publication.
Based on the outcome of this study, further improvements to the SIRIUS Endoscope System have been made to enhance safety, reliability, and usability. This proposed prospective study is a confirmatory study to evaluate the performance and safety of the SIRIUS Endoscope System in preparation for regulatory approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are planned for Laparoscopic Gynecological Surgery (LGS)
- •Patient is 18 years of age or older
- •Signed written informed consent.
排除标准
- •Patient is pregnant, or planning on becoming pregnant
- •Obese patients (BMI >35)
- •Patient with known contraindication(s) to Laparoscopic Gynecological Surgery
- •Patient with operations planned for longer than 4 hours
- •Subjects are considered ineligible for the study as judged by the investigator.
结局指标
主要结局
SIRIUS Endoscope Articulated tip assessment.
时间窗: Through study completion, Up to 1 year from the first to the last patients
SIRIUS Endoscope Articulated tip assessment, using the Questionnaire -Clinical Study Assessment of SIRIUS Endoscope System Articulated Tip
General Assessment of SIRIUS Endoscope System.
时间窗: Through study completion, Up to 1 year from the first to the last patients
General Assessment of SIRIUS Endoscope System, using Questionnaire- Clinical Study General Assessment of SIRIUS Endoscope System)
次要结局
- Events of device deficiency and/or malfunctions of SIRIUS Endoscope System(Through study completion, Up to 1 year from the first to the last patients)
- Postoperative complications related to the SIRIUS Endoscope System(Through study completion, Up to 1 year from the first to the last patients)
- The time of straight and bending positions of SIRIUS Endoscope System articulated tip(Through study completion, Up to 1 year from the first to the last patients)
- Intraoperative adverse events related to the SIRIUS Endoscope System(Through study completion, Up to 1 year from the first to the last patients)