An interventional study of Intranasal balloon tamponade device in Epistaxis and Nosebleed (Epistaxis) - Posterior or Anterior, sponsored by Atlantic Health System. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Atlantic Health System · Not applicable, Interventional, and Treatment
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.
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.
96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.
This study's planned enrollment of 50 is below the median of 64 across 81 interventional studies indexed under Epistaxis.
Browse Epistaxis studies →Atlantic Health System is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults presenting to the emergency department with epistaxis requiring nasal packing or mechanical tamponade receive the JStop™ Hemostatic Device.
Device: Intranasal balloon tamponade 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.
Number of Participants Achieving Hemostasis Without Alternative Nasal Packing or Balloon Tamponade
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.
Time frame: Within 10 minutes of device placement
No study locations are listed for this record.
Plan to share: No — There is no plan to share individual participant data with other researchers. Aggregate results will be reported.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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