跳至主要内容
临床试验/NCT01085513
NCT01085513终止不适用

Intestinal Motility Evaluation by Endoluminal Image Analysis Using Capsule Endoscopy (CE-EIA): a Multi-center Clinical Trial

Medtronic - MITG12 个研究点 分布在 5 个国家目标入组 143 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
143
试验地点
12
主要终点
To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility

研究概览

简要总结

Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world.

A novel method for evaluation of intestinal motility has been developed based on endoluminal image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is fully automated by a computer program.

The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.

This technique needs now to be validated in a large multinational population, to further develop a robust discrimination algorithm for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.

This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.

详细描述

Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility1,2,3,11, and identifies patterns of intestinal dysmotility4,8,9. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients. Furthermore, it requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world6,7,10,13.

Vall d'Hebron Hospital, in collaboration with CVC (Barcelona, Spain) have recently developed a minimally invasive method for evaluation of intestinal motility based on endoluminal image analysis using the endoscopic PillCam capsule. In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is performed fully automated by a computer program. Both the technical procedure of the test and the endoluminal image analysis program has been developed by a multidisciplinary medical-engineering team in the Autonomous University of Barcelona over the past 5 years. The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity.

In brief, the technique works as follows. In each study a series of features are analyzed: contractile patterns (contractions evaluated as a diaphragmatic occlusion of the lumen and by the presence of a radial wrinkle pattern), non contractile patterns (wall and tunnel patterns), luminal content (turbid pattern), endoluminal motion, and capsule displacement.

The program is based on an automated learning method (machine learning technique). Data from patients and healthy subjects are used as a training set. Based on these data, the program develops the function that best discriminates both groups. The performance of the system has been validated using the leave-one-out method that uses all but one as training set and evaluates the left-out example.

This technique needs now to be validated in a large multinational population. Using this expanded pool of studies as a learning set, a robust discrimination algorithm will be developed, that can be made available for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic5,12 and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved.

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
Single (Investigator)

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility

时间窗: Up to 7 months

Patients were indicated for small bowel manometry based on one or both of the following symptoms: * Pseudo obstruction * Unintentional body weight loss

次要结局

  • To Assess Correlation Between Patient Clinical Symptoms and CE-EIA(Up to 7 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (12)

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