Status:

UNKNOWN

A Digimed Oncology PharmacoTherapy Registry

Lead Sponsor:

Proteus Digital Health, Inc.

Conditions:

Colon Cancer

Breast Cancer

Eligibility:

All Genders

18+ years

Brief Summary

DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity...

Detailed Description

Patients will be prescribed the DMP and DigiMeds™ (capecitabine or supportive medications) by their healthcare provider. The pharmacy will co-encapsulate the prescribed medication with a sensor. The ...

Eligibility Criteria

Inclusion

  • Age ≥ 18
  • Prescribed treatment with DigiMeds™
  • Have an Android or iOS-enabled device (e.g., iPhone, iPad, Samsung) or be willing to use a Proteus issued iOS device
  • Signed consent form

Exclusion

  • Receiving palliative or hospice care services (i.e., proxy for \<12 months life expectancy)
  • Not proficient in the English language
  • Have impaired cognitive ability
  • For women: current pregnancy
  • Have skin sensitivity to adhesives or active/chronic dermatitis

Key Trial Info

Start Date :

September 6 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2022

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT04088955

Start Date

September 6 2019

End Date

March 1 2022

Last Update

March 11 2020

Active Locations (1)

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Carolina Blood and Cancer Care

Rock Hill, South Carolina, United States, 29732