Safety and Feasibility of the JStop™ Hemostatic Device for Nosebleeds in the Emergency Department
Epistaxis · Nosebleed (Epistaxis) - Posterior or Anterior
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 50 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This study is testing whether the JStop™ Hemostatic Device can safely and quickly stop moderate to severe nosebleeds (epistaxis) in adults treated in the emergency department. JStop is a balloon device placed in the nose that applies gentle pressure to stop bleeding, similar to nasal packing and balloon devices already in use.
About 50 adults who come to the Morristown Medical Center Emergency Department with a nosebleed that needs nasal packing will be treated with JStop. The main question is whether the device stops the bleeding within 10 minutes without the need for other packing. The study will also look at side effects, pain, how easy the device is to place and remove, and whether bleeding comes back. Participants will be seen 2 to 4 days after treatment and called at one month to check on their recovery.
Read the full description
Epistaxis is a common emergency department presentation. Moderate to severe cases often require mechanical tamponade with nasal packing, Foley catheters, or commercially available balloon devices, which can be uncomfortable, technically challenging, and sometimes ineffective, occasionally requiring repeated attempts or specialist consultation.
The JStop™ Hemostatic Device is a mechanical intranasal tamponade device intended to provide temporary hemostasis while potentially simplifying placement and improving patient tolerance. The device is considered a Non-Significant Risk (NSR) device under 21 CFR 812.3(m).
This is a prospective, single-arm, single-site pilot feasibility study at Morristown Medical Center (Atlantic Health System). Approximately 50 adults (18 years or older) presenting to the emergency department with epistaxis requiring nasal packing or mechanical tamponade, and able to provide written informed consent, will be enrolled. The treating emergency physician will place the JStop device according to its Instructions for Use. If the device fails to control bleeding or if clinically indicated, it will be removed and standard of care treatment provided immediately.
Procedural data collected include time from insertion to inflation completion, time to hemostasis, total inflation volume, need for repositioning, and immediate device success or failure. Participants will be evaluated approximately 2 to 4 days after placement and contacted by telephone at one month.
The primary outcome is achievement of hemostasis without the need for alternative nasal packing or balloon tamponade within 10 minutes of device placement. Secondary outcomes include device-related adverse events, need for additional interventions, device failure, time to hemostasis, pain scores (0 to 10) at insertion, inflation, and while in place, physician-rated ease of placement (5-point Likert scale), device stability, rebleeding within 24 hours and 7 days, ease of removal and bleeding on removal, and investigator confidence in the device as first-line treatment.
Analyses will be descriptive, with success rates reported as proportions with exact confidence intervals. No formal hypothesis testing is planned given the pilot design.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Inclusion Criteria:
1. Adults aged 18 years or older.
2. Presentation to the emergency department with epistaxis requiring nasal packing or mechanical tamponade as determined by the treating physician.
3. Ability to understand the study procedures and provide written informed consent.
4. Willingness to comply with study procedures and follow-up requirements.
Exclusion Criteria:
1. Inability to provide informed consent.
2. Known or suspected nasal or facial trauma, skull base fracture, or anatomical abnormality that would make device placement unsafe.
3. Known hypersensitivity or allergy to materials used in the study device.
4. Hemodynamic instability or medical condition requiring immediate life-saving intervention.
5. Active nasal or sinus infection that, in the judgment of the treating physician, would increase risk of complications.
6. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation.
7. Members of a vulnerable population category.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
JStop™ Hemostatic Device
Adults presenting to the emergency department with epistaxis requiring nasal packing or mechanical tamponade receive the JStop™ Hemostatic Device.
Device: Intranasal balloon tamponade device
Intranasal balloon tamponade device DEVICE
The JStop™ Hemostatic Device is a mechanical intranasal balloon tamponade device (Class I, 510(k)-exempt) placed and inflated by the treating emergency physician according to its Instructions for Use to provide temporary hemostasis in adults with epistaxis. If bleeding is not controlled, the device is removed and standard of care treatment is provided.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Number of Participants Achieving Hemostasis Without Alternative Nasal Packing or Balloon Tamponade
Time frame: Within 10 minutes of device placement
Hemostasis is defined as cessation of active bleeding after placement and inflation of the JStop™ Hemostatic Device, without the need for alternative nasal packing or balloon tamponade, as assessed by the treating emergency physician.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Atlantic Health System
- Study start
- Jan 1, 2027 Estimated
- Primary completion
- Dec 31, 2027 Estimated
- Study completion
- 2028-01 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Prospective Pilot Study Evaluating the Safety and Feasibility of the JStop™ Hemostatic Device in Patients With Epistaxis
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026