Image Quality Evaluation of Surgical Visualization Headset (Leica MyVeo) During Standard of Care Procedure Per User Manual
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- White Light and Fluorescence image quality
研究概览
简要总结
This study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue fluorescence, without needing to look through a traditional microscope. The study will involve patients undergoing brain, spine, ENT, or reconstructive surgery, where MyVeo is used as part of the standard care. Surgeons will rate the image quality, comfort, and safety of using MyVeo. The goal is to confirm that MyVeo provides clear images and supports safe and effective surgery. No extra procedures or risks are added for patients.
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 IMED-MyVeo study protocol must be appropriate patients for the applicable indication of use and have to fulfil 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.
- •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.
- •Diagnosed with condition requiring surgical intervention per user manual.
- •GLOW400 Specific Inclusion Criteria
- •Participants must have a suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which requires surgical intervention.
- •The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use.
- •GLOW800 Specific Inclusion Criteria
- •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.
- •Candidates who meet any of the following exclusion criteria will not be eligible for recruitment in the study.
排除标准
- •Any uncontrolled systemic condition that may adversely affect the surgical outcome.
- •Individuals holding United States citizenship.
- •GLOW400 Specific Exclusion Criteria
- •Known allergy to 5-ALA hydrochloride or protoporphyrin's.
- •Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).
- •GLOW800 Specific Exclusion Criteria
- •Known allergy to Indocyanine Green (ICG) cyanine dye.
- •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
White Light and Fluorescence image quality
时间窗: Periprocedural
Image quality will be assessed during surgery using a structured questionnaire completed by the operating surgeon. The evaluation includes white light and fluorescence imaging (GLOW400 and GLOW800) in both main surgeon (3D) and assistant (2D) modes. The following parameters will be rated: Contrast Color fidelity Stereoscopic/3D impression (main surgeon mode only) Resolution Latency (main surgeon mode only) Measurement Tool: MyVeo PMCF Study Data Collection Form - Questionnaire A and B Scale Range: 5-point Likert scale: 1. = Not available 2. = Insufficient 3. = Sufficient 4. = Very good 5. = Excellent Interpretation of Scores: Scores of 3 or higher are considered acceptable. Ratings below 3 indicate performance concerns. The outcome will be analyzed using binary coding (Pass = 3-5; Fail = 1-2).
次要结局
- The secondary objective will be assessed by evaluating the continued safety of the device by monitoring and analyzing adverse events, device-related complications.(Postprocedural)