Clinical trial NCT02233270: Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities
Official title: Validation of the AbStats Belt and Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) System for Analyzing Motility Abnormalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motility Disorders
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2014-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care small bowel manometry reading.
timeFrame: At the time that the standard of care diagnostic test is performed, an expected average of 6 hours
measure: Acoustic readings of the abdominal cavity and swallowing collected via the device during current standard of care SmartPill transit recording.
timeFrame: At the time the standard of care diagnostic test is performed, up to 5 days
measure: Acoustic readings of the abdominal cavity and swallowing collected via the device during standard of care breath testing.
timeFrame: At the time the standard of care diagnostic test is performed, up to 3 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Mark Pimentel, MD
role: PRINCIPAL_INVESTIGATOR
References: