Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Soft Tissue Tumors or Organs Requiring Percutaneous Biopsy as an Adjunct to Standard Image Guidance
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 104
- 试验地点
- 6
- 主要终点
- Time of Tumor Localization
研究概览
简要总结
This clinical feasibility evaluation is intended to further characterize and quantify the potential benefits of the FDA-cleared XR90 Augmented Reality (AR )imaging and guidance platform utilization in percutaneous soft tissue biopsy. This study will seek to build on the findings of safety, procedural benefits, and overall clinical feasibility shown in previous bench, cadaveric, and single-site clinical evaluations.
详细描述
This clinical evaluation is needed to further characterize and quantify the potential benefits of percutaneous biopsy, assisted with the XR90 3D surgical imaging system. This continued innovative implementation of the platform as a medical device to assist in percutaneous targeted biopsy of soft tissue tumors will allow for further assessment of device functionality, operator acceptability, and additional data collection to help quantify the potential benefits of this platform. Potential benefits to the patient, to be formally proven in future studies: decreased procedure time, decreased of complications (e.g., critical structure avoidance), and ultimately, improved patient outcomes. To date, few studies have evaluated the performance of the XR90 guidance system in a clinical setting. Comparing percutaneous needle placement for biopsies of a soft tissue target with the assistance of XR90 compared to under only standard-of-care guidance will allow for the evaluation of procedure success rate, overall procedure time, and complications. This multicenter prospective randomized control trial is designed to compare the efficacy and utility of the XR90 guidance platform used adjunct to standard of care guidance to standard of care guidance (2D) only for percutaneous needle-based procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •At least 18 years of age
- •Willing and able to give informed consent prior to enrollment
- •Subjects in need of a diagnostic soft-tissue tumor biopsy which is the primary target for needle placement as a part of their standard of care.
- •Subjects who have met all criteria to undergo percutaneous biopsy with ultrasound.
- •Subjects with soft-tissue lesions ≥1 cm or ≤8 cm in depth
- •BMI of ≤40
排除标准
- •Children under the age of
- •Currently pregnant at the time of the procedure
- •Not willing or able to give informed consent.
- •Subjects with pacemakers or AICDs.
结局指标
主要结局
Time of Tumor Localization
时间窗: Intraprocedural-from the start of the procedure until the end of the study procedure, 1 day.
The time from initiation of localization of imaging (defined by when the ultrasound probe is put into operator's hand) until operator has planned a trajectory and point of entry (by placing a finger or trocar on the skin entry site and verbalizing completion of localization) will be measured and recorded. Time is recorded in minutes and will be completed during the procedure.
Time From Skin to Target
时间窗: Intraprocedural, from the start of the procedure until the end of the study procedure, 1 day.
The elapsed time from when the proceduralist inserts their trocar or biopsy needle through the skin (excluding skin knicks) and when the provider verbalizes they have reached their intended target in order to collect a biopsy under ultrasound guidance. Time will be recorded in minutes beginning and ending during the study procedure.
次要结局
- Technical Success(Duration of the study procedure)
- Needle Attempts(Duration of the study procedure)