Nasal Valve CollapseNCT00837525
Validity Study of a Nasal Valve Implant
A study testing nasal valve implant in people with Nasal Valve Collapse, run by Nasoform, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Valve Collapse
- What is being tested?
- nasal valve implant
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has nasal valve collapse
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Metropolitan ENT and Facial Plastic Surgery
Alexandria, Virginia, 22310
About this study
Official title: Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.
- Conditions
- Nasal Valve Collapse
- Being tested
- nasal valve implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal valve implantProcedure or surgery
Injectable implantation of a biodegradable material for support of the Nasal valve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal obstruction symptom scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Valve CollapseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nasoform, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iyad S Saidi, MD PhD, Principal investigator, Metropolitan ENT and Facial Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837525
- Sponsor's protocol ID
- NVB
- Status last verified
- Feb 2009
- First submitted
- 4 Feb 2009
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.
- ClinicalTrials.gov ID
- NCT00837525
- Acronym / sponsor ID
- NVB
- Conditions
- Nasal Valve Collapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Nasoform, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 5 Feb 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.
The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has nasal valve collapse
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| nasal valve implantInjectable implantation of a biodegradable material for support of the Nasal valve. | Procedure or surgery | – |
Primary outcome
Nasal obstruction symptom scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
Related trials for Nasal Valve Collapse
Recruiting
Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction
Nasal Valve Collapse, Nose Enhancement
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.
Iyad S Saidi, MD PhD principal investigator
Metropolitan ENT and Facial Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal valve implant in people with Nasal Valve Collapse, run by Nasoform, LLC at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Nasal obstruction symptom scale (time frame: 1 year). 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 5 Feb 2009.