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PancreatitisNCT02412826

Abstats: Computer-aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Acute Pancreatitis

An observational study of Pancreatitis, run by Cedars-Sinai Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatitis
What is being tested?
Abstats sensor
Type of treatment
Medical device
How many people
20 participants
Where
1 siteUnited States
Study dates
Apr 2015to Apr 2017
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: The study population will be patients who present to Cedars-Sinai Medical Center with the diagnosis of acute pancreatitis.

Who may be able to join

  • 18 years of age and older
  • diagnosis of acute pancreatitis; must meet at least 2 out of the 3 following critiera:
  • abdominal pain consistent with acute pancreatitis
  • serum amylase/lipase >3 times upper limit of normal
  • characteristic findings from abdominal imaging
  • able to provide informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

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.

Read the detailed 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.

Conditions
Pancreatitis
Being tested
Abstats sensor
Keywords
pancreatitis, acoustic, sensor
Medical subject headings
Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abstats sensorDevice

    The AbStats abdominal biosensor will be applied to the abdomen of patients who are admitted with acute pancreatitis.

Study groups in NCT02412826
Study groupRoleWhat they receive
Acute pancreatitisPatients presenting to the hospital with acute pancreatitis that will receive AbStats sensor
Receives: Device: Abstats sensor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Re-hospitalization for acute pancreatitis

    Patients who are re-admitted to the hospital for acute pancreatitis

    Measured: 30 days

  2. Ability to PO after discharge

    Patients who are able to tolerate oral itnake after discharge

    Measured: 30 days

  3. Symptoms

    GI symptoms after discharge

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2017 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02412826
Sponsor's protocol ID
Pro00038455
Status last verified
Mar 2016
First submitted
6 Apr 2015
Last updated
2 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • Negro P, D'Amore L, Saputelli A, Talarico C, Scaccia M, Tuscano D, Gossetti F, Carboni M. Colonic lesions in pancreatitis. Ann Ital Chir. 1995 Mar-Apr;66(2):223-31.

    PubMed 7668499

  • Abcarian H, Eftaiha M, Kraft AR, Nyhus LM. Colonic complications of acute pancreatitis. Arch Surg. 1979 Sep;114(9):995-1001. doi: 10.1001/archsurg.1979.01370330017003.

    PubMed 485850

  • Russell JC, Welch JP, Clark DG. Colonic complications of acute pancreatitis and pancreatic abscess. Am J Surg. 1983 Nov;146(5):558-64. doi: 10.1016/0002-9610(83)90288-x.

    PubMed 6638261

  • Shi LL, Liu MD, Chen M, Zou XP. Involvement of interstitial cells of Cajal in experimental severe acute pancreatitis in rats. World J Gastroenterol. 2013;19(14):2179-86. doi: 10.3748/wjg.v19.i14.2179.

    PubMed 23599644

  • Leveau P, Wang X, Soltesz V, Ihse I, Andersson R. Alterations in intestinal motility and microflora in experimental acute pancreatitis. Int J Pancreatol. 1996 Oct;20(2):119-25. doi: 10.1007/BF02825510.

    PubMed 8968867

  • Seerden TC, De Man JG, Holzer P, Van den Bossche RM, Herman AG, Pelckmans PA, De Winter BY. Experimental pancreatitis disturbs gastrointestinal and colonic motility in mice: effect of the prokinetic agent tegaserod. Neurogastroenterol Motil. 2007 Oct;19(10):856-64. doi: 10.1111/j.1365-2982.2007.00968.x.

    PubMed 17883437

  • Wang X, Gong Z, Wu K, Wang B, Yuang Y. Gastrointestinal dysmotility in patients with acute pancreatitis. J Gastroenterol Hepatol. 2003 Jan;18(1):57-62. doi: 10.1046/j.1440-1746.2003.02898.x.

    PubMed 12519225

  • Davis S, Parbhoo SP, Gibson MJ. The plain abdominal radiograph in acute pancreatitis. Clin Radiol. 1980 Jan;31(1):87-93. doi: 10.1016/s0009-9260(80)80088-2.

    PubMed 7357829

  • Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.

    PubMed 20113944

  • Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

    PubMed 23896955

  • Yadav D, Lee E, Papachristou GI, O'Connell M. A population-based evaluation of readmissions after first hospitalization for acute pancreatitis. Pancreas. 2014 May;43(4):630-7. doi: 10.1097/MPA.0000000000000078.

    PubMed 24681876

  • Vipperla K, Papachristou GI, Easler J, Muddana V, Slivka A, Whitcomb DC, Yadav D. Risk of and factors associated with readmission after a sentinel attack of acute pancreatitis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1911-9. doi: 10.1016/j.cgh.2014.04.035. Epub 2014 May 9.

    PubMed 24815327

  • Tomomasa T, Morikawa A, Sandler RH, Mansy HA, Koneko H, Masahiko T, Hyman PE, Itoh Z. Gastrointestinal sounds and migrating motor complex in fasted humans. Am J Gastroenterol. 1999 Feb;94(2):374-81. doi: 10.1111/j.1572-0241.1999.00862.x.

    PubMed 10022632

  • Augustyniak P. Wearable wireless heart rate monitor for continuous long-term variability studies. J Electrocardiol. 2011 Mar-Apr;44(2):195-200. doi: 10.1016/j.jelectrocard.2010.11.014.

    PubMed 21353066

  • Shambroom JR, Fabregas SE, Johnstone J. Validation of an automated wireless system to monitor sleep in healthy adults. J Sleep Res. 2012 Apr;21(2):221-30. doi: 10.1111/j.1365-2869.2011.00944.x. Epub 2011 Aug 22.

    PubMed 21859438

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatitis, 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Mar 2016. 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?

Results are not available in the source record.

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?

Re-hospitalization for acute pancreatitis (time frame: 30 days). 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?

On the ClinicalTrials.gov record for NCT02412826, which also lists 16 linked publications.

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 2 Mar 2016.

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