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

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ClinicalTrials.gov Identifier: NCT03912051
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Dianosic

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.


Condition or disease Intervention/treatment Phase
Epistaxis Device: asymmetric balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : March 27, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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 Name: epistaxis balloon




Primary Outcome Measures :
  1. Device performance [ Time Frame: 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 [ Time Frame: 12 days ]
    Pain score on a VAS (Visual Analogic Scale)


Secondary Outcome Measures :
  1. QoL [ Time Frame: 12 days ]
    RhinoQoL (Rhino Quality of Life) score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912051


Locations
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France
CHU Strasbourg
Strasbourg, Grand Est, France, 67000
Sponsors and Collaborators
Dianosic
Investigators
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Principal Investigator: Christian Debry, Pr CHU Strasbourg (Univ Hosp Strasbourg)

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Responsible Party: Dianosic
ClinicalTrials.gov Identifier: NCT03912051     History of Changes
Other Study ID Numbers: DEF2018
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Epistaxis
Emergencies
Disease Attributes
Pathologic Processes
Hemorrhage
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms