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

NCT ID: NCT03912051

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2019-07-18

Brief 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.

Conditions

Epistaxis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

asymmetric balloon

Asymmetric air filled (max 25 cc, Leur lock syringe) epistaxis balloon

Group Type: EXPERIMENTAL

asymmetric balloon

Intervention Type: DEVICE

Asymmetric balloon for treatment of intranasal bleeding

Interventions

asymmetric balloon

Asymmetric balloon for treatment of intranasal bleeding

Intervention Type: DEVICE

Other Intervention Names

epistaxis balloon

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dianosic

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Debry, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Strasbourg (Univ Hosp Strasbourg)

Locations

CHU Strasbourg

Strasbourg, Grand Est, France

Countries

France

Other Identifiers

DEF2018

Identifier Type: -

Identifier Source: org_study_id