NCT07349485尚未招募不适用
A PAC Post-Market Clinical Study to Demonstrate Color Change in the WoundCue™ Kit When an Elevated Inhibitory Bacterial and/or Fungal Load is Present in a Wound
ParaNano, Inc.0 个研究点目标入组 50 人开始时间: 2026年1月21日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Primary Endpoint:
研究概览
简要总结
The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be considered qualified for enrollment if they meet the following criteria:
- •Subjects and/or Legally Authorized Representative (LAR) must voluntarily provide written Informed Consent, consisting of reading, signing, and dating the Informed Consent document after the Principal Investigator, sub-Principal Investigator, or other designated Study Staff member has explained the Study procedures, risks, and contact information.
- •Able and willing to comply with all Study requirements.
- •Subject can be Male or Female but must be over 21 years of age.
- •Subject is currently under the care of a Primary Care Physician.
- •Subject has an anticipated survival of greater than two months.
- •Subject has a moderate to high exudate wound that has visible fluorescence when using MolecuLightDX™ or MolecuLight i:X™ imaging.
- •Subjects will be considered qualified for enrollment if they meet the following criteria:
- •Subjects and/or Legally Authorized Representative (LAR) must voluntarily provide written Informed Consent, consisting of reading, signing, and dating the Informed Consent document after the Principal Investigator, sub-Investigator, or other designated Study Staff member has explained the Study procedures, risks, and contact information.
- •Able and willing to comply with all Study requirements.
- •Subject can be Male or Female but must be over 21 years of age.
- •Subject is currently under the care of a Primary Care Physician.
- •Subject has an anticipated survival of greater than two months.
- •Subject has a moderate to high exudate wound.
- •*For this Study, moderate exudate is defined as a wound that may require a dressing change 2-3 times a week based on provider judgement. Heavy exudate is defined as a wound that may require a dressing change 4 or more times a week based on provider judgement.
排除标准
- •Subject's target treatment area has a surface area larger than 5 cm
- •Known sensitivity or allergy to the Study Device or adhesives/adhesive-related products.
- •Current use of topical ointments, including over-the-counter products and prescription drugs, on or near the intended treatment area.
- •Current use or recent history (within the past 14 days) of antibiotics, either oral, systemic, or topical.
- •Undergoing therapy with another investigational agent that may affect the WoundCueTM Kit's performance within thirty (30) days of Study Visit 1 or planned participation overlapping with this Study.
- •Women who are pregnant, breastfeeding, or intend to become pregnant during the course of the Study.
- •Medical condition that, in the opinion of the Principal Investigator, would preclude safe Subject participation in the Study.
- •Adults who, in the judgment of the Investigator, lack the capacity to provide informed consent for themselves
研究组 & 干预措施
Arm 1 - MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent
Active Comparator
Subjects must have visible fluorescence when using MolecuLightDX™ or MolecuLight i:X™ imaging.
• Arm #1's Screening Visit requires that the standard of care MolecuLightDX™ or MolecuLight i:X™ imaging and PCR testing data taken prior to consent be obtained and used in the Study, as authorized by the Informed Consent.
干预措施: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye (Diagnostic Test)
Arm 2 - MolecuLightDX™ or MolecuLight i:X™ imaging prior to application
Active Comparator
Arm #2's Visit #1 requires that the Clinical Site scans wound with MolecuLightDX™ or MolecuLight i:X™ imaging prior to application of the WoundCue™ Kit.
干预措施: HCy-hex™: a hemicyanine-based (HCy) lipase-responsive dye (Diagnostic Test)
结局指标
主要结局
Primary Endpoint:
时间窗: 48 hours after screening
80% correlation (1:1) in detection of elevated inhibitory bacterial and/or fungal load by WoundCue™ Kit and confirmed by laboratory testing.
次要结局
未报告次要终点
研究者
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