Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Completed
NCT Number: NCT02233270
Pilot of AbStats /AEGIS System for Detecting 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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care small bowel manometry reading.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Cedars-Sinai Medical Center
Other
Collaborators
- University of California, Los Angeles
Registry information
Official study title
Validation of the AbStats Belt and Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) System for Analyzing Motility Abnormalities
Acronym: AEGIS
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 8, 2014
- Registry last updated
- Jan 29, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.