Nasal Valve CompromiseNCT02787421
Nasal Dilator Strips for Rhinoplasty
A study testing Breathe-Rite Nasal Dilator Strip in people with Nasal Valve Compromise, run by Emory University at 1 site in United States.
Trial summary
In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Valve Compromise
- What is being tested?
- Breathe-Rite Nasal Dilator Strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center
Who cannot join
- Inability to speak English
- Any disabilities that might prevent patients from completing a survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Nasal Dilator Strips for Evaluating Nasal Valve Obstruction as Measured by Post-Operative Rhinoplasty Outcomes
In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.
Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.
Read the detailed description
In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.
Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.
Additional study aims are to determine the specificity and predictive value of nasal dilator strips in determining the location of obstruction in patients with nasal valve compromise, and to assess the role of nasal dilator strips in supplementing or replacing current approaches for pre-operative evaluation of nasal valve compromise.
The target population for this study is patients at the Emory Aesthetics Center who are undergoing functional rhinoplasty for nasal valve compromise and obstruction.
- Conditions
- Nasal Valve Compromise
- Being tested
- Breathe-Rite Nasal Dilator Strip
- Keywords
- Reconstructive Surgery, Rhinoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe-Rite Nasal Dilator StripDevice
During the pre-operative clinic visit, participants will be given a Breathe-Rite Nasal Dilator Strip
| Study group | Role | What they receive |
|---|---|---|
| Functional Rhinoplasty | Experimental | Participants undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center. Receives: Device: Breathe-Rite Nasal Dilator Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nasal Obstruction and Septoplasty Effectiveness (NOSE) Instrument Score
The NOSE instrument is a highly sensitive assessment of nasal obstruction using participant-reported subjective symptoms. The highest possible score is 100. A higher score indicates more severe nasal congestion symptoms.
Measured: Prior to surgery and again at 6-10 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Study withdrawn - changing study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Valve CompromiseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Sethna, Emory University
- Investigators
- Anita Sethna, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787421
- Sponsor's protocol ID
- IRB00086968
- Status last verified
- Jun 2017
- First submitted
- 20 May 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Nasal Dilator Strips for Evaluating Nasal Valve Obstruction as Measured by Post-Operative Rhinoplasty Outcomes
- ClinicalTrials.gov ID
- NCT02787421
- Acronym / sponsor ID
- IRB00086968
- Conditions
- Nasal Valve Compromise
- Keywords
- Reconstructive Surgery, Rhinoplasty
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn - changing study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 Jun 2016 (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.
In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.
Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.
Detailed description
In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.
Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.
Additional study aims are to determine the specificity and predictive value of nasal dilator strips in determining the location of obstruction in patients with nasal valve compromise, and to assess the role of nasal dilator strips in supplementing or replacing current approaches for pre-operative evaluation of nasal valve compromise.
The target population for this study is patients at the Emory Aesthetics Center who are undergoing functional rhinoplasty for nasal valve compromise and obstruction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Rhinoplasty | Experimental | Device: Breathe-Rite Nasal Dilator StripParticipants undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center
Key exclusion criteria (2 listed)
- Inability to speak English
- Any disabilities that might prevent patients from completing a survey
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 |
|---|---|---|
| Breathe-Rite Nasal Dilator StripDuring the pre-operative clinic visit, participants will be given a Breathe-Rite Nasal Dilator Strip | Device | Functional Rhinoplasty |
Primary outcome
Change in Nasal Obstruction and Septoplasty Effectiveness (NOSE) Instrument Score
Time frame: Prior to surgery and again at 6-10 weeks after surgery
The NOSE instrument is a highly sensitive assessment of nasal obstruction using participant-reported subjective symptoms. The highest possible score is 100. A higher score indicates more severe nasal congestion symptoms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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.
Anita Sethna, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathe-Rite Nasal Dilator Strip in people with Nasal Valve Compromise, run by Emory University 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 2 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: withdrawn, as of the sponsor's last update on 14 Jun 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Nasal Obstruction and Septoplasty Effectiveness (NOSE) Instrument Score (time frame: Prior to surgery and again at 6-10 weeks after surgery). 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 14 Jun 2017.