Frontal SinusitisSIBANCT02509663
Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons
A study testing Functional Endoscopic Sinus Surgery, Functional Endoscopic Sinus Surgery using rigide instrumentation and Sinuplasty balloon in people with Frontal Sinusitis, run by University Hospital, Strasbourg, France at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontal Sinusitis
- What is being tested?
- Functional Endoscopic Sinus Surgery, Functional Endoscopic Sinus Surgery using rigide instrumentation and Sinuplasty balloon
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Jun 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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...)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin
Bordeaux, 33000
Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Service ORL et de Chirurgie Cervico-Faciale
Nantes, 44000
Service ORL et de Chirurgie Maxillo-Faciale et Plastique Hôpital Lariboisière
Paris, 75000
Service ORL Institut Arthur Vernes
Paris, 75000
Service ORL, chirurgie maxillo-faciale et audiophonologie CHU - Hôpital de la Miletrie
Poitiers, 86000
ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals
Strasbourg, 67000
Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey
Toulouse, 31000
About this study
Official title: Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial
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.
Read the 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.
- Conditions
- Frontal Sinusitis
- Being tested
- Functional Endoscopic Sinus Surgery, Functional Endoscopic Sinus Surgery using rigide instrumentation, Sinuplasty balloon, Endoscope
- Medical subject headings
- Frontal Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Endoscopic Sinus SurgeryProcedure or surgery
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.
Functional Endoscopic Sinus Surgery using rigide instrumentationProcedure or surgery
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sinuplasty balloon | Active comparator | Patients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty Receives: Procedure: Functional Endoscopic Sinus Surgery; Device: Sinuplasty balloon |
| Conventional surgical procedure | Active comparator | Patients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation Receives: Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation; Device: Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: This ratio will be assessed for 12 months post surgery
Secondary outcomes (3)
Quality of the patient's life
Patient's quality of life include the following exams :
- EuroQoL EQ-5D Questionnaire
- SNOT-22 questionnaire
Measured: 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
Risks associated with intervention include the following criteria :
- Occurrence of surgical times
- Occurrence of complications
- Presence of opacification in the visible sinus CT
Measured: This secondary outcome will be assessed for 12 month
Economic impact of the sinuplasty balloon
Measured: economic impact of this inovative technique will be assessed from sinus intervention to month 12 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study start15 Jun 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Why it stopped: the manufacturer of the device has been bought and the new company does not want to continue the study anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontal SinusitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Christian Debry, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509663
- Sponsor's protocol ID
- 6190
- Acronym
- SIBA
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2015
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial
- ClinicalTrials.gov ID
- NCT02509663
- Acronym / sponsor ID
- SIBA / 6190
- Conditions
- Frontal Sinusitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the manufacturer of the device has been bought and the new company does not want to continue the study anymore
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinuplasty balloon | Active comparator | Procedure: Functional Endoscopic Sinus Surgery, Device: Sinuplasty balloonPatients will receive the innovative health technology to treat frontal sinusitis : a balloon sinuplasty |
| Conventional surgical procedure | Active comparator | Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation, Device: EndoscopePatients will be treated with the conventional procedure : a sinus surgery with rigide instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Endoscopic Sinus SurgeryBalloon 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. | Procedure or surgery | Sinuplasty balloon |
| Functional Endoscopic Sinus Surgery using rigide instrumentationFESS (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. | Procedure or surgery | Conventional surgical procedure |
| Sinuplasty balloonBalloon 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. | Device | Sinuplasty balloon |
| EndoscopeFESS (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. | Device | Conventional surgical procedure |
Primary outcome
Cost-utility ratio
Time frame: This ratio will be assessed for 12 months post surgery
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
3 secondary outcomes
Quality of the patient's life
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
Risks associated with intervention
Time frame: This secondary outcome will be assessed for 12 month
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
Results and safety
The study was stopped early (reason given: the manufacturer of the device has been bought and the new company does not want to continue the study anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Related trials for Frontal Sinusitis
Not yet recruiting
Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative Study ).
Chronic Rhinosinusitis (CRS), Frontal Sinusitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Debry principal investigator
Strasbourg's University Hospitals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Endoscopic Sinus Surgery, Functional Endoscopic Sinus Surgery using rigide instrumentation and Sinuplasty balloon in people with Frontal Sinusitis, run by University Hospital, Strasbourg, France at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the manufacturer of the device has been bought and the new company does not want to continue the study anymore). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-utility ratio (time frame: This ratio will be assessed for 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.