Validation of the AbStats Belt and Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) System for Analyzing Motility Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care small bowel manometry reading.
研究概览
简要总结
When compared to existing analyses: manometry, Smart Pill and lactulose breath testing, external Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) may identify unique audible patterns characteristic of features of gastroinestinal (GI) motility, gastric and small bowel contractions and emptying and small intestinal bacterial overgrowth (SIBO). This research study is designed to test the capabilities of AbStats/AEGIS to identify and associate symptoms and traditional diagnostics with sound readings and correlate this data with treatment outcomes and successes in standard of care.
详细描述
In partnership with Dr. William Kaiser and the UCLA Wireless Health Institute, our research groups are developing and validating the diagnostic capabilities of device that conducts AEGIS. A belt (AbStats) fits externally around the abdomen and is embedded with acoustic sensors, similar to "electronic stethoscopes." The investigational software is designed to continuously, safely, and comfortably monitor acoustic signals emanating from the esophagus, stomach, and intestines, and stores the data in a HIPAA compliant hard drive. Through the study of associating these readings with current diagnostics and treatments we anticipate that the AEGIS device will eventually provide clinically interpretable information that is immediately actionable. In this study, the Abstats sensor will track signals in tandem with current techniques and standard of care treatments based on those diagnostics. AEGIS analysis could potentially refine, support, or even replace, existing costly and invasive techniques in the diagnosis of gastroparesis, intestinal psueodo-obstruction, colonic inertia, and disorders related to small intestinal bacterial overgrowth (SIBO).
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
- •≥ 18 years old
- •Scheduled for a small bowel manometry, SmartPill, or lactulose hydrogen breath test in the Cedars-Sinai Motility Program
排除标准
- •Body mass index that is incompatible with placement of the belt (typically BMI greater than 45)
- •Abdominal wall condition that disallows topical coverage as deemed by treating physician (eg abdominal wound, advanced cellulitis, draining ostomy etc)
- •Inability to consent
- •Have cognitive inability to follow directions
结局指标
主要结局
Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care small bowel manometry reading.
时间窗: At the time that the standard of care diagnostic test is performed, an expected average of 6 hours
Acoustic readings would be recorded concurrent with standard of care diagnostics. There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.
Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care SmartPill transit recording.
时间窗: At the time the standard of care diagnostic test is performed, up to 5 days
Acoustic readings would be recorded concurrent with standard of care diagnostics. There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.
Acoustic readings of the abdominal cavity and swallowing collected via the device during standard of care breath testing.
时间窗: At the time the standard of care diagnostic test is performed, up to 3 hours.
Acoustic readings would be recorded concurrent with standard of care diagnostics. There is no study follow up. Any patient follow up would be solely clinical standard of care, independent of study data or findings.
次要结局
未报告次要终点
研究者
Mark Pimentel, MD
Director, GI Motility Program
Cedars-Sinai Medical Center