Study of a Smart Sharps Disposal Device in Patients With Hemophilia

NCT07421154 | Not Yet Recruiting

• 1 other identifier: 851363
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hemophilia A and B

Keywords

hemophilia

Outcome Measures

Primary Outcomes (1)

• Adherence

  % from baseline to active phase that patient adheres to using needle disposal

  Days 1-180

Secondary Outcomes (1)

• Patient and provider satisfaction survey

  Day 181 +/- 7 days

Study Arms (1)

intervention of being given device to use

EXPERIMENTAL

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.

Interventions

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. 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.

intervention of being given device to use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharpscue: collaborator
• University of Pennsylvania: lead

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Blood Disorders Program

Philadelphia, Pennsylvania, 19130-3805, United States

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Allyson Pishko, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allyson Pishko, MD

CONTACT

215-615-6555; Allyson.Pishko@pennmedicine.upenn.edu

Karen Panckeri, MBE

CONTACT

215-615-6555; Karen.Panckeri@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Everyone gets a Sharps needle disposal device.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At end of study for 7 years after publication
• Access Criteria: Requests for de-identified data will be emailed to PI and to be reviewed by PI and local IRB

Locations

US (2)