Smart Sharps Disposal Device for Hemophilia

Not yet recruiting at 1 trial location
KP
AP
Overseen ByAllyson Pishko, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pennsylvania
Must be taking: Factor products, Emicizumab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smart sharps disposal device for people with hemophilia, a condition where blood doesn’t clot properly. The device safely disposes of needles used for injecting hemophilia medication at home. Researchers aim to determine if patients and healthcare providers find the device easy and convenient to use. Individuals with moderate or severe Hemophilia A or B who regularly inject medication at least every two weeks may be suitable for this trial. As an unphased trial, it offers a chance to contribute to innovative solutions for safer home care.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you must be on a regular schedule of hemophilia medication, either a factor product or emicizumab, at least once every 14 days.

What prior data suggests that this smart sharps disposal device is safe for use by hemophilia patients?

Research has shown that smart sharps disposal devices are generally safe in healthcare settings. Studies have found that these devices can help reduce needlestick injuries, which occur when a needle accidentally pierces the skin. For example, one study found that using these devices lowered the number of sharps injuries in hospitals. Although specific data on using this exact smart sharps disposal device at home is lacking, the goal is to make needle disposal safer and easier, indicating a positive sign for safety. Always follow the instructions for any new device to ensure safety.12345

Why are researchers excited about this trial?

Researchers are excited about the Smart Sharps Disposal Device for hemophilia because it offers a safer and more convenient way to dispose of needles used in treatment. Unlike traditional sharps containers, this device is designed to be user-friendly and minimize the risk of accidental needle sticks, which is a significant concern for those managing hemophilia. The innovative design of the device aims to enhance safety and ease of use, potentially improving the quality of life for individuals who require regular injections.

What evidence suggests that this smart sharps disposal device is effective for hemophilia?

Studies have shown that smart devices can help people with hemophilia better manage their treatment, including tracking medication schedules. In this trial, participants will use a smart sharps disposal device, which provides patients and doctors with real-time data on treatment results, such as pain and bleeding. These tools may help patients adhere to their treatment plans and improve their overall health. Although the smart sharps disposal device is new, early signs suggest it could simplify hemophilia management for patients.12346

Who Is on the Research Team?

AP

Allyson Pishko, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) with moderate or severe Hemophilia A or B, who self-inject their medication at least once every 14 days. People can't join if a home nurse gives their infusions, they can't use the device, are on other experimental treatments, or inject less often.

Inclusion Criteria

I am 18 years old or older.
I have moderate or severe Hemophilia A or B.
I am on regular preventive treatment for bleeding, given at least every 14 days.

Exclusion Criteria

I receive my infusions from a nurse at home.
Stated inability to use the SharpsCue container
Treatment with another investigational drug or other intervention during the study period
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a smart sharps disposal container at home for disposal of needles used to administer their hemophilia drugs

180 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Smart Sharps Disposal Device

Trial Overview

The study tests a smart sharps disposal container used at home to throw away needles after hemophilia treatment. It checks if patients and providers find it easy and acceptable to use.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: intervention of being given device to useExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Sharpscue

Collaborator

Citations

Study of a Smart Sharps Disposal Device in Patients With ...

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 ...

Study of a Smart Sharps Disposal Device in Patients With ...

This pilot study will have patients use a smart sharps disposal container at home for disposal of needles used to administer their ...

Study of a Smart Sharps Disposal Device in Patients With ...

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 ...

Hemophilia: Reducing Treatment Burden with Pen Devices

Further patient-reported outcomes show that patients feel more confident in their ability to self-administer the drug with pens, as they find ...

Study of a Smart Sharps Disposal in Patients With Hemophilia

Preventative factor or non-factor product IV administration has been shown to improve outcomes in patients with hemophilia. The need for ...

Hemophilia: Reducing Treatment Burden with Pen Devices

What can we learn from patient-reported outcomes of insulin pen devices? J ... Burden of treatment on people with hemophilia: global real- world data.