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Combining Ostom-I With Abstats Sensors to Improve Prediction of Ostomy Output

NCT02909634 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-08-10

No results posted yet for this study

Summary

Currently, the number of patients having either permanent or temporary stomas placed is increasing each year. Yet, patients with ostomy pouches often struggle with predicting when stool output will occur and how to plan around dynamic changes in intestinal activity. Ostom-I provides a real-time assessment of the volume in the ostomy bag, it does not predict when and how fast such output will occur. In this pilot study the investigators aim to gather normative AbStats and Ostom-I data in participants with an ostomy to improve prediction of stool output.

Aim 1: To gather normative AbStats and Ostom-I data in subjects with an ostomy to improve prediction of stool output.

Aim 2: Correlate the data from both wearable biosensors and test the predictive validity of AbStats in determining ostomy bag filling as measured by Ostom-I.

Conditions

  • Ostomy

Sponsors & Collaborators

  • 11 Heath and Technologies Limited

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Christopher V Almario, MD, MSHPM · Cedars-Sinai Medical Center

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2018-08-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02909634 on ClinicalTrials.gov