Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities (AEGIS)

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.

Study Overview

• Status: Completed
• Conditions: Motility Disorders

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).

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Cedars-Sinai Motility Program who are already scheduled to undergo small bowel manometry, SmartPill, or Lactulose Hydrogen Breath Test.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care small bowel manometry reading.	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.	At the time that the standard of care diagnostic test is performed, an expected average of 6 hours
Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care SmartPill transit recording.	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.	At the time the standard of care diagnostic test is performed, up to 5 days
Acoustic readings of the abdominal cavity and swallowing collected via the device during standard of care breath testing.	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.	At the time the standard of care diagnostic test is performed, up to 3 hours.

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: University of California, Los Angeles
• Investigators: Principal Investigator: Mark Pimentel, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 32500