Overview

This trial is active, not recruiting.

Condition motility disorders
Sponsor Cedars-Sinai Medical Center
Collaborator University of California, Los Angeles
Start date July 2013
End date July 2017
Trial size 10 participants
Trial identifier NCT02233270, 32500

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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 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 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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Validation of the AbStats Belt and Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) System for Analyzing Motility Abnormalities
Principal investigator Mark Pimentel, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cedars-Sinai Medical Center.