NCT07611318Enrolling By Invitation不适用
Confirmatory Study of Substantial Equivalence Between cureVision cV and MolecuLight i:X in Detecting Bacterial Burden in Wounds
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 5
研究概览
简要总结
The study aims to demonstrate the substantial equivalence of the cureVision cV system's performance in detecting moderate to high bacterial loads in direct comparison to the comparator device for fluorescence imaging in wounds, the MolecuLight i:X , to be able to offer the complete cureVision cV system to the US market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 22 years
- •Eligible wounds include all wound etiologies including but not limited to DFUs, VLUs, pressure injuries, and open postsurgical wounds.
- •Presence of at least one target wound of sufficient size to allow:
- •Complete imaging using the investigational device, and collection of tissue biopsy samples, as required by the study protocol
- •- The target wound must be located in an anatomical region that permits: Full visualization, appropriate positioning for imaging, and safe and feasible biopsy sampling.
- •Written informed consent possible
- •Wound suitable for fluorescence imaging under IFU conditions with the study device and the comparator device (e.g., no excessive exudate obscuring visualization
排除标准
- •The target wound cannot be completely imaged by the comparator device due to anatomical location, such as wounds that are:
- •Too extensive to be captured within the device's field of view, positioned on curved, recessed, or otherwise inaccessible regions (e.g., deep sacral clefts, interdigital spaces).
- •The target wound is too small to support the required biopsy procedures without compromising participant safety or data quality.
- •Treatment with experimental medication within the last month
- •Lack of ability to consent
- •Contraindications for standard wound care or monitoring
- •Strong therapeutic anticoagulation (e.g., direct oral anticoagulants and warfarin);
- •Known bleeding diathesis or coagulation disorder that increases risk of biopsy-related complications
- •Contraindications to local anesthesia or biopsy
- •Patients with wounds that are not suitable for biopsy, including tunnelling wounds and wounds with fistula formation
- •Wounds that cannot meet technical imaging requirements (e.g., excessive exudate, severe artifacts, calcification/crust preventing visualization).
研究组 & 干预措施
cureVision cV
Active Comparator
combination of CSS and fluorescence imaging with cureVision cV system
干预措施: cureVision cV (Diagnostic Test)
研究者
研究点 (5)
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