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

Sponsor
Dianosic (Industry)
Overall Status
Completed
CT.gov ID
NCT03912051
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
3.7
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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

  1. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: asymmetric balloon
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Performance and Safety of an Asymmetric Balloon in the Treatment of Intranasal Bleeding Managed in an Emergency Setting
Actual Study Start Date :
Mar 27, 2019
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jul 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: asymmetric balloon

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

Device: asymmetric balloon
Asymmetric balloon for treatment of intranasal bleeding
Other Names:
  • epistaxis balloon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Device performance [12 days]

      Absence of bleeding following balloon inflation during first 48 hours and absence of rebreeding following removal at 48 hours and 9 days following removal

    2. Device safety [12 days]

      Pain score on a VAS (Visual Analogic Scale)

    Secondary Outcome Measures

    1. QoL [12 days]

      RhinoQoL (Rhino Quality of Life) score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Strasbourg Strasbourg Grand Est France 67000

    Sponsors and Collaborators

    • Dianosic

    Investigators

    • Principal Investigator: Christian Debry, Pr, CHU Strasbourg (Univ Hosp Strasbourg)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dianosic
    ClinicalTrials.gov Identifier:
    NCT03912051
    Other Study ID Numbers:
    • DEF2018
    First Posted:
    Apr 11, 2019
    Last Update Posted:
    Sep 3, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Epistaxis
    Emergencies

    Study Results

    No Results Posted as of Sep 3, 2019