Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting

Study Overview
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Brief Summary
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Between 10 and 12% of the general population suffers from epistaxis, out of which 10% would need to be medically managed. Most of patients treated for epistaxis are managed through emergency departments. The involvement of the ENT (ear, nose and throat) surgeon might be required in more complex situations in order to control bleeding. Usually, nasal packing packing is used as a first line option after failure of digital compression. Epistaxis balloons are often used after failure of nasal packing Balloons are effective in approximately 60% of the patients with a rapid control of bleeding by compression followed by an absence of rebreeding after balloon removal. The main challenges for patients treated with this device are i) pain upon balloon introduction and inflation ii) discomfort upon introduction in the nasal cavity as well as during balloon maintenance during 24 to 72 hours of tamponade iii) blood retention between distal and proximal balloons that favors infection iv) limited breathing capabilities through the nostrils which increases general discomfort v) negative aesthetic impact for the patient vi) septal and alar necrosis risk in case of prolonged compression. Moreover, epistaxis leading to an hospitalization between 24 to 48h are not rare (>11 000 in France in 2017 according to ATIH). Those hospitalizations are often decided in order to ensure an optimal patient monitoring following packing or epistaxis balloon placement. In order to address those adverse events while keeping the same efficacy and avoiding hospitalizations or reducing their duration, the use of an asymmetric, more physiological, easy to use and mainly intranasal (discreet proximal extremity) is studied.

Official Title
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Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting

Conditions
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Epistaxis

Intervention / Treatment
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* Device: asymmetric balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 18 years Male and female bleeding uncontrolled with digital compression Patient registered at social security Patient who gave informed consent Exclusion Criteria: Allergy to xylocaine Impossibility to give patient information (severe massive epistaxis, difficulty to understand, non awaken patient…) Patient in custody of court Patient under guardianship or curator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: asymmetric balloon<br>Asymmetric air filled (max 25 cc, Leur lock syringe) epistaxis balloon | Device: asymmetric balloon<br>* Asymmetric balloon for treatment of intranasal bleeding<br>* Other names: epistaxis balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device performance | Absence of bleeding following balloon inflation during first 48 hours and absence of rebreeding following removal at 48 hours and 9 days following removal | 12 days | 
| Device safety | Pain score on a VAS (Visual Analogic Scale) | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL | RhinoQoL (Rhino Quality of Life) score | 12 days |