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Not yet recruitingNCT07421154Updated Jul 9, 2026

Study of a Smart Sharps Disposal Device in Patients With Hemophilia

An interventional study of 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. in Hemophilia A and B, sponsored by University of Pennsylvania. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemophilia A and B

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Keywords

  • hemophilia
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's planned enrollment of 23 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.

Browse Hemophilia A studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (estimated)

Study arms

  • 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.

Interventions

  • OtherThe 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.

06

What researchers measure

Primary outcomes

  1. Adherence

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

    Time frame: Days 1-180

Secondary outcomes

  1. Patient and provider satisfaction survey

    Patient and provider satisfaction survey

    Time frame: Day 181 +/- 7 days

07

Study locations

2 sites
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Penn Blood Disorders Program
    Philadelphia, Pennsylvania 19130-3805, United States
08

References and documents

Individual participant data

Plan to share: Yes — Request for de-identified data will be reviewed by PI

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07421154
Lead sponsor
University of Pennsylvania
Collaborators
Sharpscue
Responsible party
Allyson Pishko (Assistant Professor, University of Pennsylvania) — Principal investigator
First posted
Feb 19, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jan 30, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Jul 9, 2026

Study contacts

Allyson Pishko, MD
Contact
Allyson.Pishko@pennmedicine.upenn.edu
215-615-6555
Karen Panckeri, MBE
Contact
Karen.Panckeri@pennmedicine.upenn.edu
215-615-6555
Allyson Pishko, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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