NCT03912051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

April 8, 2019

Last Update Submit

August 30, 2019

Conditions

Epistaxis

Outcome Measures

Primary Outcomes (2)

  • 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

  • Device safety

    Pain score on a VAS (Visual Analogic Scale)

    12 days

Secondary Outcomes (1)

  • QoL

    12 days

Study Arms (1)

asymmetric balloon

EXPERIMENTAL

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

Device: asymmetric balloon

Interventions

asymmetric balloonDEVICE

Asymmetric balloon for treatment of intranasal bleeding

Also known as: epistaxis balloon
asymmetric balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years
  • Male and female
  • bleeding uncontrolled with digital compression
  • Patient registered at social security
  • Patient who gave informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Strasbourg

Strasbourg, Grand Est, 67000, France

Location

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Christian Debry, Pr

    CHU Strasbourg (Univ Hosp Strasbourg)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 11, 2019

Study Start

March 27, 2019

Primary Completion

June 30, 2019

Study Completion

July 18, 2019

Last Updated

September 3, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)