Atrophic RhinitisRANCT00832403
Gore Tex Implants in the Treatment of Atrophic Rhinitis
An observational study of Atrophic Rhinitis, run by Hospital Felicio Rocho.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrophic Rhinitis
- What is being tested?
- implants of polytetrafluoroethylene in tha nasal fossa
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that were submit to surgery to treat atrophic rhinitis with implants in the nasal fossa.
Who may be able to join
- Symptoms of atrophic rhinitis, with previous clinical treatment without good results
Who cannot join
- Patients with mental illness
About this study
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.
Read the detailed description
Data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. The symptoms and complications were described.
- Conditions
- Atrophic Rhinitis
- Being tested
- implants of polytetrafluoroethylene in tha nasal fossa
- Keywords
- atrophic rhinitis, implants, Polytetrafluoroethylene
- Medical subject headings
- Rhinitis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implants of polytetrafluoroethylene in tha nasal fossaOther
surgical implants of polytetrafluoroethylene in the nasal fossa
| Study group | Role | What they receive |
|---|---|---|
| polytetrafluoroethylene | Not described Receives: Other: implants of polytetrafluoroethylene in tha nasal fossa |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of fetid crusts and atrophy of the mucous bone covering
Measured: after surgery recovery
Secondary outcomes (1)
lack of side effects such as infection
Measured: after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startNov 2006
- Primary completionFeb 2008
Why it stopped: lack of new patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Felicio Rocho
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832403
- Sponsor's protocol ID
- Rinite Atrófica cep/hfr
- Acronym
- RA
- Status last verified
- Jan 2009
- First submitted
- 27 Jan 2009
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gore Tex Implants in the Treatment of Atrophic Rhinitis
- ClinicalTrials.gov ID
- NCT00832403
- Acronym / sponsor ID
- RA / Rinite Atrófica cep/hfr
- Conditions
- Atrophic Rhinitis
- Keywords
- atrophic rhinitis, implants, Polytetrafluoroethylene
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: lack of new patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospital Felicio RochoUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Feb 2008 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polytetrafluoroethylene | – | Other: implants of polytetrafluoroethylene in tha nasal fossa |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that were submit to surgery to treat atrophic rhinitis with implants in the nasal fossa.
Key inclusion criteria (1 listed)
- Symptoms of atrophic rhinitis, with previous clinical treatment without good results
Key exclusion criteria (1 listed)
- Patients with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implants of polytetrafluoroethylene in tha nasal fossasurgical implants of polytetrafluoroethylene in the nasal fossa | Other | polytetrafluoroethylene |
Primary outcome
improvement of fetid crusts and atrophy of the mucous bone covering
Time frame: after surgery recovery
1 secondary outcome
lack of side effects such as infection
Time frame: after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrophic Rhinitis, run by Hospital Felicio Rocho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of fetid crusts and atrophy of the mucous bone covering (time frame: after surgery recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.