This trial is active, not recruiting.

Condition pancreatitis
Treatment abstats sensor
Sponsor Cedars-Sinai Medical Center
Start date April 2015
End date April 2017
Trial size 20 participants
Trial identifier NCT02412826, Pro00038455


The purpose of this study is to conduct a pilot test of an abdominal acoustic sensor on patients with acute pancreatitis to determine the correlation of acoustic signals with symptoms reported by the patient.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients presenting to the hospital with acute pancreatitis that will receive AbStats sensor
abstats sensor
The AbStats abdominal biosensor will be applied to the abdomen of patients who are admitted with acute pancreatitis.

Primary Outcomes

Re-hospitalization for acute pancreatitis
time frame: 30 days
Ability to PO after discharge
time frame: 30 days
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years of age and older - diagnosis of acute pancreatitis; must meet at least 2 out of the 3 following critiera: 1. abdominal pain consistent with acute pancreatitis 2. serum amylase/lipase >3 times upper limit of normal 3. characteristic findings from abdominal imaging - able to provide informed consent Exclusion Criteria: - unable to provide consent - transfer patients - cognitive inability to follow directions to maintain sensors in place - unable to place abdominal sensors on patients - abdominal cellulitis - pregnant women

Additional Information

Official title Abstats: Computer-aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Acute Pancreatitis
Principal investigator Elham Afghani, MD
Description This study will use the AbStats device, that measure IAAS (intraabdominal acoustic signals) and intestinal rate and will correlate this data with symptoms reported by patients hospitalized for acute pancreatitis. The AbStats multi-sensor wireless abdominal monitoring system includes low profile acoustic sensors that are applied to the anterior abdominal wall with Tegaderm and monitors sounds emanating from the GI tract. The acoustic sensors continuously and non-invasively monitor and capture audio signals representing GI and abdominal wall function. The captured data is recorded in a synchronized manner from all sensors. We will place the AbStats sensor on all patients immediately after admission to the hospital. Only study staff trained on the AbStats system will apply the sensors, which fit externally around the abdomen. A physician member of our study staff will be available at all times to help position the device if needed. We will continuously record AbStats acoustic signals for the duration of the hospitalization, with the option to discontinue as clinically required or requested by the provider or patient. A research coordinator will collect clinical data from medical records and enter the data into a secure spreadsheet on CSMC servers. Patients will be asked to keep a daily diary of symptoms. In this diary, the patients will be asked to record information about their food consumption (if any), bowel movements (if any and if associated with contrast from CT imaging or with the use of suppositories/ laxative), specific symptoms, and whether the sensor was removed for any period of time during the day. This will allow us to compare the data collected by the AbStats sensor with self-reported symptoms noted by patients. Physicians and nurses will not be made aware of the AbStats readings so as to eliminate the Hawthorne effect. Patients will be managed according to standard-of-care practice and the data collected by the AbStats device will not be incorporated into clinical care.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Cedars-Sinai Medical Center.