Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities

NCT ID: NCT02233270

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-10-31

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).

Conditions

Motility Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mark Pimentel, MD

Director, GI Motility Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Pimentel, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

32500

Identifier Type: -

Identifier Source: org_study_id