跳至主要内容
临床试验/NCT06899113
NCT06899113招募中不适用

Correlating Multispectral Near-Infrared Imaging to Standard Vascular Diagnostics

MIMOSA Diagnostics Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Correlation coefficient between MIMOSA measures to standard vascular assessment modalities

研究概览

简要总结

The goal of this observational study is to learn if the measures of tissue oxygenation from the MIMOSA Pro imaging device correlate to standard vascular assessment tools in patients who receiving a lower extremity vascular assessment.

The main questions it aims to answer are:

  • Do the MIMOSA Pro tissue oxygenation measures correlate to Ankle-Brachial Index, Toe-Brachial Index, transcutaneous oximetry, and Doppler wave forms?
  • Do the MIMOSA Pro tissue oxygenation measures correlate with disease classifications for peripheral arterial disease, venous disease, and wound stage?
  • Is the MIMOSA Pro able to measure vascular status more often than other modalities?

Participants will be asked to follow standard of care, and also allow for their legs to imaged by the MIMOSA Pro.

详细描述

Observational non-interventional study to assess the use of multispectral near-infrared (MS-NIR) imaging as an adjunct tool in the wound center. No clinical decisions will be made based on information obtained through the use of the MIMOSA device. Objectives are to correlate tissue oxygen saturation (StO2) by MS-NIR to measures by standard vascular diagnostic tools, including ankle-brachial index (ABI), toe-brachial index (TBI), transcutaneous oximetry, Doppler waveforms. Also to assess the ability of MS-NIR to support the classification and grading severity of patients' peripheral artery disease (PAD), venous disease and wound healing and to evaluate the clinical workflow utility of MS-NIR as an adjunct tool in the wound center. The study will recruit patients 18 years old and older, are undergoing an ankle-brachial index exam and recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms). Participants will be asked to allow for imaging of their lower extremities with the MIMOSA Pro. Investigator will assess participants on their disease and wound status. They will also perform vascular assessments mentioned above as per standard of care. Participants will be followed for 2 months as per regularly scheduled visits. The standard vascular assessment results and disease/wound status will then be correlated with the measures from the MIMOSA Pro.

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

  • •Provision of signed and dated informed consent form
  • •Stated willingness to comply with all study procedures and availability for the duration of the study
  • •Male or female, aged 18 and older
  • •Patient is undergoing an ABI test.
  • •Patient recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms)
  • •Patients who can be followed by the same investigating team for the whole period of their participation in the study.

排除标准

  • •Patients who are participating in another clinical study for ulcer management
  • •Patients who are unable to understand the aims of the study and not able to provide informed consent
  • •Receiving radiation to the extremity
  • •Active charcot joints

结局指标

主要结局

Correlation coefficient between MIMOSA measures to standard vascular assessment modalities

时间窗: From baseline to the end of study at 2 months

次要结局

  • Correlation coefficient between MIMOSA measures to disease and/or wound status(From baseline to the end of study at 2 months)

研究者

发起方
MIMOSA Diagnostics Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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