NCT02822781

Brief Summary

Chronic rhinosinusitis (CRS) is a debilitating disease that remains (smell, nasal patency, flow) because currently treatment protocols available to us are with a limited efficacy. The assessment of the response to surgical treatment protocols and monitoring the become of patients treated with only drugs should allow investigators to identify the predictive patient's profile for the response. With this prospective data, this study would allow investigators to make a classification of Chronic rhinosinusitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2016

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

June 30, 2016

Last Update Submit

September 7, 2017

Conditions

RHINOPLASTYNASAL SURGICAL PROCEDURES

Outcome Measures

Primary Outcomes (1)

  • Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 points

    Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 points

    Day1, Month 6

Secondary Outcomes (1)

  • Assessment of change of endoscopic nasal in consultation

    Day1, Month 6

Interventions

No interventionOTHER

There is no intervention. The patients will receive common questionnaire usually used by doctors (SNOT 22). Some Data to describe the population are collected then.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with bilateral chronic rhinosinusitis evolving for more than 3 months with diffuse sinus opacities scanner.

You may qualify if:

  • Patients with bilateral chronic rhinosinusitis evolving for more than 3 months with diffuse sinus opacities scanner.

You may not qualify if:

  • Rhino Sinusitis unilateral
  • Background total or functional ethmoidectomy (but not polypectomy)
  • immunodeficiency or immunosuppression in patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

L'Institut Arthur vernes

Paris, Île-de-France Region, 75014, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

Study Officials

  • SAUVAGET Elisabeth, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Study Start

November 1, 2015

Primary Completion

April 30, 2016

Study Completion

July 21, 2016

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

FR(3)