Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:1/31/2018
Start Date:July 2013
End Date:October 2014

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

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.

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).

Inclusion Criteria:

- ≥ 18 years old

- Scheduled for a small bowel manometry, SmartPill, or lactulose hydrogen breath test in
the Cedars-Sinai Motility Program

Exclusion Criteria:

- 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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Mark Pimentel, MD
Phone: 310-423-3792
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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