NCT02509663

Brief Summary

The sinuplasty balloon offers a more physiological first of the sinuses which minimizes risks associated to traditional surgery. Its atraumatic characteristic also helps to reduce the risk of bleeding (so any use of Pack), limit scarring ransom, reduce the post-operative pain, ensure faster return to daily life activities (reduction of the average length of hospitalization). Patient's quality of life would be improved (SNOT-22 questionnaire) and reduction of post-operative pain score seams decrease on EVA. The economic impact of the sinuplasty balloon appears very favourable and fits into the strategy of development of the ambulatory practice.

Trial Health

57
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Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

8 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

July 17, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
2.9 years until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

July 17, 2015

Last Update Submit

March 5, 2020

Conditions

Frontal Sinusitis

Outcome Measures

Primary Outcomes (1)

  • Cost-utility ratio

    Cost-utility ratio will be assessed with : * cost difference between sinuplasty balloon and conventional surgery * utility difference of these two surgery procedures estimated with EQ-5D questionnaire outcomes

    This ratio will be assessed for 12 months post surgery

Secondary Outcomes (3)

  • Quality of the patient's life

    This secondary outcome will be assessed for 12 month : at inclusion and at 1 Week , 3 weeks , 3 -6 and 12 months post surgery

  • Risks associated with intervention

    This secondary outcome will be assessed for 12 month

  • Economic impact of the sinuplasty balloon

    economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery

Study Arms (2)

Sinuplasty balloon

ACTIVE COMPARATOR

Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty

Procedure: Functional Endoscopic Sinus SurgeryDevice: Sinuplasty balloon

Conventional surgical procedure

ACTIVE COMPARATOR

Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation

Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentationDevice: Endoscope

Interventions

Functional Endoscopic Sinus SurgeryPROCEDURE

Balloon Sinuplasty uses a small, flexible, balloon catheter to open up blocked sinus passageways and facilitate drainage of the mucus that builds up in patients suffering from frontal sinusitis symptoms. When the sinus balloon is inflated, it restructures and widens the walls of the sinus passageway while maintaining the integrity of the sinus lining.

Sinuplasty balloon
Functional Endoscopic Sinus Surgery using rigide instrumentationPROCEDURE

FESS (Functional Endoscopic Sinus Surgery) using rigide instrumentation is conventional therapeutic strategy. The procedure works by cutting to remove bone and tissue to enlarge the sinus opening.

Conventional surgical procedure
Sinuplasty balloonDEVICE

Balloon Sinuplasty uses a small, flexible, balloon catheter to open up blocked sinus passageways and facilitate drainage of the mucus that builds up in patients suffering from frontal sinusitis symptoms. When the sinus balloon is inflated, it restructures and widens the walls of the sinus passageway while maintaining the integrity of the sinus lining.

Sinuplasty balloon
EndoscopeDEVICE

FESS (Functional Endoscopic Sinus Surgery) using rigide instrumentation is conventional therapeutic strategy. The procedure works by cutting to remove bone and tissue to enlarge the sinus opening.

Conventional surgical procedure

Eligibility Criteria

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

You may qualify if:

  • Man or woman of age ≥ to 18 years.
  • Patient for which a frontal sinus surgery (Draf 1 type) is programmed for any type of frontal sinusitis unresponsive to drug treatment properly leads.
  • Patient affiliated to a social protection scheme Written informed consent of the patient
  • Signed informed consent

You may not qualify if:

  • Polyposis sinonasal or other sinus to be the subject of a simultaneous complementary intervention
  • Sinuso-nasal tumors
  • Osteogenesis
  • Fragile patients or patient needing gesture contraindicating surgery by rigid instrumentation
  • Contraindication with balloon using
  • Contraindication to general anesthesia
  • Immunosuppressive therapy
  • Patient under judicial protection
  • Pregnancy or Breastfeeding
  • Contrast medium allergy background
  • Impossibility to give the informed study documentation to the subject (emergency situation, lack of understanding, etc...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin

Bordeaux, 33000, France

Location

Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

Service ORL et de Chirurgie Cervico-Faciale

Nantes, 44000, France

Location

Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière

Paris, 75000, France

Location

Service ORL Institut Arthur Vernes

Paris, 75000, France

Location

Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie

Poitiers, 86000, France

Location

ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals

Strasbourg, 67000, France

Location

Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Frontal Sinusitis

Interventions

Endoscopes

Condition Hierarchy (Ancestors)

SinusitisRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesSurgical Equipment

Study Officials

  • Christian Debry

    Strasbourg's University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 28, 2015

Study Start

June 15, 2018

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

FR(8)