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Study of a Smart Sharps Disposal Device in Patients With Hemophilia

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University of Pennsylvania

Status

Not yet enrolling

Conditions

Hemophilia A and B

Treatments

Other: The smart Sharps device is given to the patient and they use it to throw needles away in. It is not internal to the patient.

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This pilot study will have patients use a smart sharps disposal container at home for disposal of needles used to administer their hemophilia drugs. The study aims to find out if the smart sharps container proved acceptable to use by patients and medical providers and can be adhered to.

Full description

Preventative factor or non-factor product IV administration has been shown to improve outcomes in patients with hemophilia. The need for patients to log their doses or complete questionnaires can be burdensome. This study seeks to use novel technology, a smart sharps container that records disposal of the needle used to administer preventive products. We will perform a prospective study of adult patients with hemophilia A/B who are on factor or non-factor products. They will all be given the device to take home and use there.

Enrollment

23 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

  • Male or female, ≥18 years of age
  • Moderate or Severe Hemophilia A or B, with or without an inhibitor
  • Prescribed prophylaxis with either a factor product or emicizumab that is scheduled to be given at least once every 14 days

Exclusion:

  • Stated inability to use the SharpsCue container
  • Treatment with another investigational drug or other intervention during the study period
  • Patients on prophylactic dosing less than once every 14 days
  • Patients who are infused by a home nurse

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

intervention of being given device to use
Experimental group
Description:
needle disposal device
Treatment:
Other: The smart Sharps device is given to the patient and they use it to throw needles away in. It is not internal to the patient.

Trial contacts and locations

2

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Central trial contact

Allyson Pishko, MD; Karen Panckeri, MBE

Data sourced from clinicaltrials.gov

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