← Back to all trials
Not Yet Recruiting
NCT07928739
Safety and Feasibility of the JStop™ Hemostatic Device for Nosebleeds in the Emergency Department
Conditions: Epistaxis, Nosebleed (Epistaxis) - Posterior or Anterior
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Atlantic Health System
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07928739). StuddyBuddy aggregates publicly available trial information.