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Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons (SIBA)

Primary Purpose

Frontal Sinusitis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Endoscopic Sinus Surgery
Functional Endoscopic Sinus Surgery using rigide instrumentation
Sinuplasty balloon
Endoscope
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frontal Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Exclusion period determinated with concurrent participation in other experimental studies
  • Contrast medium allergy background
  • Impossibility to give the informed study documentation to the subject (emergency situation, lack of understanding, etc...)

Sites / Locations

  • Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin
  • Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil
  • Service ORL et de Chirurgie Cervico-Faciale
  • Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière
  • Service ORL Institut Arthur Vernes
  • Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie
  • ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals
  • Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sinuplasty balloon

Conventional surgical procedure

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of the patient's life
Patient's quality of life include the following exams : EuroQoL EQ-5D Questionnaire SNOT-22 questionnaire
Risks associated with intervention
Risks associated with intervention include the following criteria : Occurrence of surgical times Occurrence of complications Presence of opacification in the visible sinus CT
Economic impact of the sinuplasty balloon

Full Information

First Posted
July 17, 2015
Last Updated
March 5, 2020
Sponsor
University Hospital, Strasbourg, France
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02509663
Brief Title
Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons
Acronym
SIBA
Official Title
Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
the manufacturer of the device has been bought and the new company does not want to continue the study anymore
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The primary objective is to estimate the cost-utility ratio of the sinuplasty balloon after frontal sinus surgery, compared to surgery by rigid instrumentation, in a randomized single-blind controlled study. The secondary objectives is to compare: the two types of surgery the quality of life the feeling of pain in patients but also the occurrence of surgical times or complications between the two proposed techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontal Sinusitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sinuplasty balloon
Arm Type
Active Comparator
Arm Description
Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty
Arm Title
Conventional surgical procedure
Arm Type
Active Comparator
Arm Description
Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation
Intervention Type
Procedure
Intervention Name(s)
Functional Endoscopic Sinus Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Functional Endoscopic Sinus Surgery using rigide instrumentation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sinuplasty balloon
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Endoscope
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost-utility ratio
Description
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
Time Frame
This ratio will be assessed for 12 months post surgery
Secondary Outcome Measure Information:
Title
Quality of the patient's life
Description
Patient's quality of life include the following exams : EuroQoL EQ-5D Questionnaire SNOT-22 questionnaire
Time Frame
This secondary outcome will be assessed for 12 month : at inclusion and at 1 Week , 3 weeks , 3 -6 and 12 months post surgery
Title
Risks associated with intervention
Description
Risks associated with intervention include the following criteria : Occurrence of surgical times Occurrence of complications Presence of opacification in the visible sinus CT
Time Frame
This secondary outcome will be assessed for 12 month
Title
Economic impact of the sinuplasty balloon
Time Frame
economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Exclusion period determinated with concurrent participation in other experimental studies Contrast medium allergy background Impossibility to give the informed study documentation to the subject (emergency situation, lack of understanding, etc...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Debry
Organizational Affiliation
Strasbourg's University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Service ORL et de Chirurgie Cervico-Faciale
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Service ORL Institut Arthur Vernes
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

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Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons

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