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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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

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Frontal Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Sinuplasty balloon

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

Group Type ACTIVE_COMPARATOR

Functional Endoscopic Sinus Surgery

Intervention Type PROCEDURE

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

Intervention Type DEVICE

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.

Conventional surgical procedure

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

Group Type ACTIVE_COMPARATOR

Functional Endoscopic Sinus Surgery using rigide instrumentation

Intervention Type PROCEDURE

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.

Endoscope

Intervention Type DEVICE

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.

Interventions

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Functional Endoscopic Sinus 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.

Intervention Type PROCEDURE

Functional Endoscopic Sinus Surgery using rigide instrumentation

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 PROCEDURE

Sinuplasty balloon

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

Endoscope

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

Eligibility Criteria

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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...)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No