Study of a Smart Sharps Disposal Device in Patients With Hemophilia

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: Hemophilia A and B
• Intervention / 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.

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

• Study Contact: Name: Allyson Pishko, MD; Phone Number: 215-615-6555; Email: Allyson.Pishko@pennmedicine.upenn.edu
• Study Contact Backup: Name: Karen Panckeri, MBE; Phone Number: 215-615-6555; Email: Karen.Panckeri@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
      • Contact: Karen Panckeri, MBE; Phone Number: 215-615-6555; Email: Karen.Panckeri@pennmedicine.upenn.edu
      • Contact: Primary Investigator; Phone Number: 215-615-6555; Email: Allyson.Pishko@pennmedicine.upenn.edu
      • Principal Investigator: Allyson Pishko, MD
    • Philadelphia, Pennsylvania, United States, 19130-3805
      • Penn Blood Disorders Program

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	% 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	Patient and provider satisfaction survey	Day 181 +/- 7 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Sharpscue
• Investigators: Principal Investigator: Allyson Pishko, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 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): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hemophilia
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Hemophilia A
• 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