NCT01296919

Brief Summary

Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 13, 2011

Status Verified

February 1, 2011

Enrollment Period

4 months

First QC Date

February 14, 2011

Last Update Submit

September 11, 2011

Conditions

Rhinosinusitis

Keywords

Chronic rhinosinusitisHistopathologyInfundibulumLamina propriaUncinate process

Study Arms (1)

Sinus drainage

Adult patients with chronic rhinosinusitis who failed treatment with antibiotics and topical corticosteroids and underwent endoscopic sinus surgery. Preoperative evaluation included paranasal sinus CT scans. The diagnosis was confirmed by endoscopic examination showing purulent and/or mucopurulent discharge in the middle and/or superior meatus.

Eligibility Criteria

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

Patients with chronic rhinosinusitis whose uncinate process had to be removed to enable surgical access to the sinuses.

You may qualify if:

  • Patients with chronic rhinosinusitis who:
  • Failed conservative medical treatment.
  • Stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.
  • Had a Lund-MacKay CT score of 2 and higher of 24 available.

You may not qualify if:

  • Immunosuppressed patients.
  • Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
  • Patients with a Lund-MacKay CT score \< 2 of 24 available.
  • Pregnant women.
  • Patients who underwent prior endoscopic sinus surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssutaHS

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pathologic uncinate process tissue

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Gilead Berger, MD

    AssutaHS, Meir Medical Center

    PRINCIPAL INVESTIGATOR

  • Eitan Yaniv, MD

    Assuta Hospital Systems

    STUDY CHAIR

  • Roee Landsberg, MD

    Assuta Hospital Systems

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 16, 2011

Study Start

March 1, 2010

Primary Completion

July 1, 2010

Study Completion

December 1, 2011

Last Updated

September 13, 2011

Record last verified: 2011-02

Locations

IL(1)