Gore Tex Implants in the Treatment of Atrophic Rhinitis | NCT00832403

Studies
Gore Tex Implants in the Treatment of Atrophic Rhinitis

NCT00832403

Sponsor

Hospital Felicio Rocho

Status

Suspended

Last Update Posted

Jan 30, 2009Estimated

Enrollment

5Actual

Phase

Not provided

Conditions

Atrophic Rhinitis

Interventions

implants of polytetrafluoroethylene in tha nasal fossa

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of new patients

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Not provided

First Submitted Date

Jan 27, 2009

First Submission Date that Met QC Criteria

Jan 29, 2009

First Posted Date

Jan 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2009

Last Update Posted Date

Jan 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. The symptoms and complications were described.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
polytetrafluoroethylene			Other: implants of polytetrafluoroethylene in tha nasal fossa

Interventions

Name	Type	Description	Arm Group Labels	Other Names
implants of polytetrafluoroethylene in tha nasal fossa	Other	surgical implants of polytetrafluoroethylene in the nasal fossa	polytetrafluoroethylene

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvement of fetid crusts and atrophy of the mucous bone covering		after surgery recovery

Secondary Outcomes

Measure	Description	Time Frame
lack of side effects such as infection		after the treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with mental illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012222	Rhinitis, Atrophic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided