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

Epistaxis Clinical Trial

— BATSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912051
• Other study ID #: DEF2018
• Status: Completed
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: July 18, 2019

Study information

• Verified date: August 2019
• Source: Dianosic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 18, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Epistaxis

Intervention

Device:
• asymmetric balloon
Asymmetric balloon for treatment of intranasal bleeding

Locations

Country	Name	City	State
France	CHU Strasbourg	Strasbourg	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Dianosic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Device safety	Pain score on a VAS (Visual Analogic Scale)	12 days
Secondary	QoL	RhinoQoL (Rhino Quality of Life) score	12 days