Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
TERMINATED
NCT02509663
NA

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

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

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.

Official title: Medico-economic Evaluation of the Balloon Sinuplasty as Mini-invasive Treatment of Frontal Sinusitis by a Randomized Multicenter Prospective Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2018-06-15

Completion Date

2019-07-31

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

PROCEDURE

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.

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.

DEVICE

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.

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.

Locations (8)

Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin

Bordeaux, France

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

Créteil, France

Service ORL et de Chirurgie Cervico-Faciale

Nantes, France

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

Paris, France

Service ORL Institut Arthur Vernes

Paris, France

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

Poitiers, France

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

Strasbourg, France

Service ORL et de Chirurgie Cervico-Faciale Hôpital Larrey

Toulouse, France