NCT02233270

Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities

Validation of the AbStats Belt and Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) System for Analyzing Motility Abnormalities

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Motility Disorders

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-09-08
• Last updated: 2018-01-29

Locations

1 site across 1 country: United States