NCT00832403

Brief Summary

This is a retrospective study, involving patients with atrophic rhinitis, that underwent Gore tex® implants in the nasal fossa. The Fetid Rhinitis or Atrophic Ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. Diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. Currently, its etiology remains unknown. As there isn't any ideal treatment already established, this technique improves the options of treatment. All patients have improved after the procedure.

Trial Health

20
At Risk

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
5

participants targeted

Target at below P25 for all trials

Status
suspended

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

January 27, 2009

Last Update Submit

January 29, 2009

Conditions

Atrophic Rhinitis

Keywords

atrophic rhinitisimplantsPolytetrafluoroethylene

Outcome Measures

Primary Outcomes (1)

  • improvement of fetid crusts and atrophy of the mucous bone covering

    after surgery recovery

Secondary Outcomes (1)

  • lack of side effects such as infection

    after the treatment

Study Arms (1)

polytetrafluoroethylene

Other: implants of polytetrafluoroethylene in tha nasal fossa

Interventions

implants of polytetrafluoroethylene in tha nasal fossaOTHER

surgical implants of polytetrafluoroethylene in the nasal fossa

polytetrafluoroethylene

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that were submit to surgery to treat atrophic rhinitis with implants in the nasal fossa.

You may qualify if:

  • Symptoms of atrophic rhinitis, with previous clinical treatment without good results

You may not qualify if:

  • Patients with mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Atrophic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 30, 2009

Study Start

November 1, 2006

Primary Completion

February 1, 2008

Last Updated

January 30, 2009

Record last verified: 2009-01