跳至主要内容
临床试验/NCT03611361
NCT03611361终止不适用

Wound Imaging System to Gather Clinical References: Collection of Clinical References Images for the Second Generation DeepView Wound Imaging System

SpectralMD1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2015年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
55
试验地点
1
主要终点
Standardized amputation healing assessment

研究概览

简要总结

This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.

详细描述

SpectralMD has developed an imaging device (DeepView), which simultaneously performs multispectral imaging (MSI) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. These optical measurements are integrated using a CADe algorithm to categorize microvascular blood flow and provide a quantitative assessment to aid in selecting the appropriate amputation site.

The investigators intend to gather data to train the CADe algorithm to predict ultimate healing status of tissue in the lower extremities of individuals suffering from peripheral arterial disease (PAD). The investigators will demonstrate the feasibility of using such an algorithm to accurately predict the location and extent of small vessel disease prior to amputation. Eventually, the invesitgators expect the DeepView to reduce the rate of re-amputation in patients with peripheral arterial disease if used for routine assessment of patients prior to amputation.

The aims of the study are as follows:

  • Evaluate performance of a Computer Assisted Detection (CADe) algorithm trained to assist selecting the level-of-amputation in patients with PAD.
  • Identify multispectral signatures that are strongly predictive of viable skin tissue at proposed amputation sites.
  • Create a representative database for training the CADe algorithm.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Patient must require amputation on a limb secondary to PAD, defined as arterial insufficiency due to atherosclerosis based on one or more of the following assessments:
  • Ankle brachial index;
  • Duplex ultrasonography showing clinically significant occlusion;
  • Arteriography; or
  • Assessment demonstrating stenosis by arterial calcification.
  • Able to give informed consent,
  • Be at least 18 years of age.

排除标准

  • No history of major amputation on the affected limb, or
  • Life expectancy less than 6 months.

结局指标

主要结局

Standardized amputation healing assessment

时间窗: 30-days

Healing as indicated by: re-epithelialization of tissue within the incision site and no signs of drainage/exudate.

次要结局

  • Standardized amputation healing assessment(90-days)

研究者

发起方
SpectralMD
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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