Study of a Smart Sharps Disposal Device in Patients With Hemophilia

July 7, 2026 updated by: Allyson Pishko, University of Pennsylvania

Study of a Smart Sharps Disposal in Patients With Hemophilia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19130-3805
        • Penn Blood Disorders Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention of being given device to use
needle disposal device
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Days 1-180
% from baseline to active phase that patient adheres to using needle disposal
Days 1-180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and provider satisfaction survey
Time Frame: Day 181 +/- 7 days
Patient and provider satisfaction survey
Day 181 +/- 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Sharpscue

Investigators

  • Principal Investigator: Allyson Pishko, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 851363

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Request for de-identified data will be reviewed by PI

IPD Sharing Time Frame

At end of study for 7 years after publication

IPD Sharing Access Criteria

Requests for de-identified data will be emailed to PI and to be reviewed by PI and local IRB

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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