Fluorescence Visualization and Image Quality Evaluation of Digital Visualization During Standard of Care Procedure in the Cerebral Vascular Area as Well as Blood Flow During Plastic and Reconstructive Surgery (PRS) (Leica GLOW800)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Fluorescence visibility.
研究概览
简要总结
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope. The study evaluates fluorescence visualization and image quality during standard surgical procedures in the cerebral vascular area and plastic and reconstructive surgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.
详细描述
The IMED-GLOW800 study is designed to collect clinical data on the GLOW800 device, a CE-marked surgical microscope accessory developed by Leica Microsystems. The device enables enhanced intraoperative visualization of blood flow using Indocyanine Green (ICG) fluorescence, integrated into the surgical field in real-time with stereoscopic depth perception.
Traditional ICG-guided surgery often requires switching between anatomical and fluorescence views, which can interrupt surgical workflow. GLOW800 overcomes this limitation by digitally overlaying fluorescence signals onto the anatomical view, improving surgical decision-making and workflow efficiency.
The study will enroll 31 patients across at least two sites in the European Economic Area (EEA) and Switzerland. Eligible patients will undergo standard surgical procedures in the cerebral vascular area or plastic and reconstructive surgery. The study does not involve additional invasive procedures and is conducted entirely within the scope of routine care.
The primary objective is to assess the performance of GLOW800 in terms of fluorescence visibility and image quality. Secondary objectives include evaluating the continued safety of the device. Data will be collected using structured questionnaires completed by surgeons during and after surgery, along with video recordings captured by the microscope.
Endpoints include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for the study must be appropriate patients for surgical interventions in the cerebral vascular area or for plastic and reconstructive surgery and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.
- •Participants must be 18 years of age or older at the time of signing the informed consent.
- •Participants must have a condition requiring surgical intervention in the cerebral vascular area as well as during plastic and reconstructive surgery.
- •The Indocyanine Green (ICG) cyanine dye is administered as a contrast agent per instructions for use.
- •The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study
排除标准
- •Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.
- •Known allergy to Indocyanine Green (ICG) cyanine dye.
- •Any uncontrolled systemic condition that may adversely affect the surgical outcome.
- •Patients holding United States citizenship.
- •Severe iodine-induced reactions to macromolecular iodine-containing compounds (e.g., iodinated contrast media, iodine-based antiseptics, or drugs like amiodarone), especially if the reaction involved anaphylaxis or respiratory compromise.
结局指标
主要结局
Fluorescence visibility.
时间窗: Periprocedural
Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: 1. Perceived fluorescence visibility in monochrome view 2. Perceived fluorescence visibility in pseudo color view 3. Anatomical and fluorescence observation 4. Fluorescence information given by Indocyanine Green (ICG) 5. Fluorescence information about vessel architecture 6. Fluorescence information about blood flow 7. Fluorescence information about capillary transition 8. Fluorescence information about drainage over venous blood vessels Each item is rated on a 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).
Image quality
时间窗: Periprocedural
Performance will be evaluated using Questionnaire, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: 1. Stereoscopic Perception (3D Depth perception) 2. Resolution 3. Latency Each item is rated on a 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).
Anatomical background
时间窗: Periprocedural
Performance will be evaluated using Questionnaire A, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: The visibility of anatomical structures are rated. Each item is rated on a 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better.)
Visibility of real time vascular blood flow
时间窗: Periprocedural
Performance will be evaluated using Questionnaire A, a structured Likert-scale survey completed by the operating surgeon during and after surgery. The questionnaire assesses: Visibility of real-time vascular blood flow Each item is rated on a 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Higher scores indicate better performance. The outcome is considered acceptable if all ratings are ≥3 (Sufficient or better).
次要结局
- The secondary objectives of this Post-Market Clinical Follow-up (PMCF) study are to assess the continued safety of the device.(Postoperatively)