Epistaxis Clinical Trial
Official title:
Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting
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.
n/a
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