跳至主要内容
临床试验/NCT03774485
NCT03774485已完成不适用

Longitudinal Study of Myoelectric GutPrint of Healthy Controls and Crohn's Disease Patients During Flare and Remission

Stanford University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Myoelectric activity pattern (physiological parameters)

研究概览

简要总结

A feasibility study for assessing and recording myoelectric activity in patients for early detection of flare in patients with Crohn's disease and differentiating the myoelectric signals from Crohn's disease patients in remission state and healthy controls.

详细描述

Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares despite aggressive therapy. Flares are often difficult to predict. The goal of disease monitoring is to identify patients at risk for flare in order to treat earlier, with the hope of maintaining remission and avoiding irreversible bowel damage such as fistulas and strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows in some cases ability to predict flare and determine deep remission, this procedure is invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility patterns in CD flare and remission states may be helpful for prediction of flare for guiding appropriate therapy.

The goal of this study is to determine whether the motility patterns measured by the G-Tech non-invasive, wireless patch system can provide useful insight for routine CD care. Three G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch to carry with them for the next 3-6 days. Data from the patches is processed offline to obtain motility patterns of the stomach, small intestine and colon. These patterns represent a rich trove of data that can be studied in multiple ways to provide comparisons and insight. Some examples are the overall strength of motor activity in each of the organs, the duration and rhythmicity, the correlation with meals, pain events and bowel movements, day to day variations and their correlation with symptoms, and diurnal effects.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.

排除标准

  • Patients or subjects under the age of 18, pregnant, and those unable to give consent or follow direction.
  • Healthy subjects with gastrointestinal symptoms or history of gastrointestinal surgeries.
  • Patients with severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery.
  • Patients with bowel surgeries due to potential impact on the G-Tech results. For similar reasons we will exclude patients on new medications (e.g. within 3 months of enrollment) known to alter GI motility but we will not exclude patients on stable doses or chronic GI motility agents as this mimics "real world" in which the G-Tech patch will be used and we can learn the stability of the motility recordings over time in stable patients.

结局指标

主要结局

Myoelectric activity pattern (physiological parameters)

时间窗: change from baseline at 1 month, 3 months and 6 months after recruitment

Myoelectric activity pattern in Crohn's disease patients versus healthy controls

次要结局

  • Number of unanticipated adverse device effects(Up to 6 days)
  • Number of anticipated Adverse Events(Up to 6 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sidhartha Ranjit Sinha

Assistant Professor

Stanford University

研究点 (1)

Loading locations...

相似试验