Motility DisordersAEGISNCT02233270
Pilot of AbStats /AEGIS System for Detecting Motility Abnormalities
An observational study of Motility Disorders, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motility Disorders
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 18 years old
- Scheduled for a small bowel manometry, SmartPill, or lactulose hydrogen breath test in the Cedars-Sinai Motility Program
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the time the standard of care diagnostic test is performed, up to 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJul 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motility DisordersStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Mark Pimentel, MD, Cedars-Sinai Medical Center
- Investigators
- Mark Pimentel, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233270
- Sponsor's protocol ID
- 32500
- Acronym
- AEGIS
- Status last verified
- Jan 2018
- First submitted
- 20 Aug 2014
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the AbStats Belt and Acoustic Esophago-Gastro-Intestinal Surveillance (AEGIS) System for Analyzing Motility Abnormalities
- ClinicalTrials.gov ID
- NCT02233270
- Acronym / sponsor ID
- AEGIS / 32500
- Conditions
- Motility Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jul 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥ 18 years old
- Scheduled for a small bowel manometry, SmartPill, or lactulose hydrogen breath test in the Cedars-Sinai Motility Program
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Pimentel, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motility Disorders, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.