Study of a Smart Sharps Disposal Device in Patients With... | NCT07421154

Studies
Study of a Smart Sharps Disposal Device in Patients With Hemophilia

NCT07421154

Sponsor

University of Pennsylvania

Status

Not yet recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

23Estimated

Phase

Not Applicable

Conditions

Hemophilia A and B

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.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2026Estimated

Primary Completion Date

Jan 30, 2027Estimated

Completion Date

Jan 30, 2027Estimated

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Feb 16, 2026

First Posted Date

Feb 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2026

Last Update Posted Date

Jul 9, 2026Actual

Name	Class
Sharpscue	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Allyson Pishko, MD	Contact	215-615-6555		Allyson.Pishko@pennmedicine.upenn.edu
Karen Panckeri, MBE	Contact	215-615-6555		Karen.Panckeri@pennmedicine.upenn.edu

Overall Officials

Name	Affiliation	Role
Allyson Pishko, MD	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Request for de-identified data will be reviewed by PI

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided