Safety and Feasibility of the JStop™ Hemostatic Device for Nosebleeds in the Emergency Department
Epistaxis · Nosebleed (Epistaxis) - Posterior or Anterior
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 50 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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.
¿Quién podría participar?
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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.
Tratamiento, grupos y participación
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- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Number of Participants Achieving Hemostasis Without Alternative Nasal Packing or Balloon Tamponade
Plazo: 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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- Atlantic Health System
- Inicio del estudio
- 1 ene 2027 Estimado
- Finalización primaria
- 31 dic 2027 Estimado
- Finalización del estudio
- 2028-01 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Prospective Pilot Study Evaluating the Safety and Feasibility of the JStop™ Hemostatic Device in Patients With Epistaxis
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026