Nasal Valve IncompetenceNCT03131115
Lateral Crural Strut Graft vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency
A study testing Lateral Crural Strut Graft and Bone Anchored Suspension in people with Nasal Valve Incompetence, run by Stanford University at 1 site in United States.
Trial summary
Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose. 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 Incompetence
- What is being tested?
- Lateral Crural Strut Graft and Bone Anchored Suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Nov 2018
- 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
- Eligible subjects with be healthy, adults with lateral nasal wall collapse with or without septal deviation, turbinate hypertrophy, or narrowed internal nasal valve. They must have failed prior medical management with topical nasal steroid or topical or oral antihistamines. They must be able to read, sign, and demonstrate understanding of the research protocol, including agreement to randomization for treatment of their lateral nasal wall collapse
Who cannot join
- All subjects shall be excluded with evidence or history of prior rhinoplasty, immunocompromise, smokers, chronic sinusitis, history of radiation to the head and neck, septal perforation, granulomatous disease, or pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Facial Plastics and Reconstructive Surgery, Stanford University
Palo Alto, California, 94304
About this study
Official title: Lateral Crural Strut Graft vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency: A Randomized Clinical Trial.
Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is another well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the two well known and universally used treatments to each other. Based on expert opinions these procedures are both safe and efficient but given lack of randomized clinical trials comparing these 2 techniques, it is difficult to extrapolate which procedure is superior.
Read the detailed description
Patients with lateral nasal wall collapse who are eligible for surgical repair will be presented with the opportunity to participate. Once consented, standard pre-operative evaluation will be performed including evaluation of degree of lateral nasal wall collapse. They will also be screened with validated quality of life screening tools for nasal congestion, which include the NOSE scale and a visual analog scale. They will then be randomized to treatment either with Lateral crura strut graft or bone anchored suture suspension, in combination with likely other areas of functional rhinoplasty such as septoplasty and turbinate reduction. All of our patients will be seen 1 week, 2-3 month and 1 year after surgery
- Conditions
- Nasal Valve Incompetence
- Being tested
- Lateral Crural Strut Graft, Bone Anchored Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Crural Strut GraftProcedure or surgery
Also called LCSG ( lateral crural strut graft)
surgical technique as described
Bone Anchored SuspensionProcedure or surgery
Also called BAST(Bone Anchored Suspension technique)
Surgical technique as described
| Study group | Role | What they receive |
|---|---|---|
| Lateral Crural Strut Graft | Active comparator | Lateral crura strut graft is a well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. Receives: Procedure: Lateral Crural Strut Graft |
| Bone-Anchored suspension | Active comparator | Bone- Anchored suspension is a well described surgical technique which involves anchoring the nasal sidewall to the bony rim below the eye. Receives: Procedure: Bone Anchored Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op
Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific questionnaire for the assessment of Nasal Obstruction (NO)
Measured: 1 year
Secondary outcomes (3)
Visual Analogue Scale for nasal obstruction
The scale is a 10-cm horizontal line anchored by word descriptors. It is scored by measuring the distance in millimeters from the left of where the patient's mark was placed. A higher number indicates more severe symptoms.
Measured: 1 year
Visual analogue scale for satisfaction with appearance of the nose
The scale is a 10-cm horizontal line anchored by word descriptors. It is scored by measuring the distance in millimeters from the left of where the patient's mark was placed. A higher number indicates higher degree of satisfaction
Measured: 1 year
physician derived lateral wall insufficiency grading system
This is a validated grading system which is measured by physician based on degrees of nasal valve insufficiency
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 posted27 Apr 2017
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Why it stopped: Not able to enroll patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nasal Valve IncompetenceStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam P. Most, Stanford University
- Investigators
- Sam P Most, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131115
- Sponsor's protocol ID
- 39000
- Status last verified
- Jul 2018
- First submitted
- 24 Apr 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no plan to share IPD
Publications
Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
PubMed 14990910Tsao GJ, Fijalkowski N, Most SP. Validation of a grading system for lateral nasal wall insufficiency. Allergy Rhinol (Providence). 2013 Summer;4(2):e66-8. doi: 10.2500/ar.2013.4.0054.
PubMed 24124639Most SP. Comparing Methods for Repair of the External Valve: One More Step Toward a Unified View of Lateral Wall Insufficiency. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):345-6. doi: 10.1001/jamafacial.2015.0790. No abstract available.
PubMed 26247486
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Crural Strut Graft vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03131115
- Acronym / sponsor ID
- 39000
- Conditions
- Nasal Valve Incompetence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to enroll patient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 27 Apr 2017 (actual)
- 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.
Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is another well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the two well known and universally used treatments to each other. Based on expert opinions these procedures are both safe and efficient but given lack of randomized clinical trials comparing these 2 techniques, it is difficult to extrapolate which procedure is superior.
Detailed description
Patients with lateral nasal wall collapse who are eligible for surgical repair will be presented with the opportunity to participate. Once consented, standard pre-operative evaluation will be performed including evaluation of degree of lateral nasal wall collapse. They will also be screened with validated quality of life screening tools for nasal congestion, which include the NOSE scale and a visual analog scale. They will then be randomized to treatment either with Lateral crura strut graft or bone anchored suture suspension, in combination with likely other areas of functional rhinoplasty such as septoplasty and turbinate reduction. All of our patients will be seen 1 week, 2-3 month and 1 year after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral Crural Strut Graft | Active comparator | Procedure: Lateral Crural Strut GraftLateral crura strut graft is a well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. |
| Bone-Anchored suspension | Active comparator | Procedure: Bone Anchored SuspensionBone- Anchored suspension is a well described surgical technique which involves anchoring the nasal sidewall to the bony rim below the eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible subjects with be healthy, adults with lateral nasal wall collapse with or without septal deviation, turbinate hypertrophy, or narrowed internal nasal valve. They must have failed prior medical management with topical nasal steroid or topical or oral antihistamines. They must be able to read, sign, and demonstrate understanding of the research protocol, including agreement to randomization for treatment of their lateral nasal wall collapse
Key exclusion criteria (1 listed)
- All subjects shall be excluded with evidence or history of prior rhinoplasty, immunocompromise, smokers, chronic sinusitis, history of radiation to the head and neck, septal perforation, granulomatous disease, or 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 |
|---|---|---|
| Lateral Crural Strut GraftAlso: LCSG ( lateral crural strut graft)surgical technique as described | Procedure or surgery | Lateral Crural Strut Graft |
| Bone Anchored SuspensionAlso: BAST(Bone Anchored Suspension technique)Surgical technique as described | Procedure or surgery | Bone-Anchored suspension |
Primary outcome
NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op
Time frame: 1 year
Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific questionnaire for the assessment of Nasal Obstruction (NO)
3 secondary outcomes
Visual Analogue Scale for nasal obstruction
Time frame: 1 year
Visual analogue scale for satisfaction with appearance of the nose
Time frame: 1 year
physician derived lateral wall insufficiency grading system
Time frame: 1 year
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 17 Jul 2018.
- Background: PubMed 14990910Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
- Background: PubMed 24124639Tsao GJ, Fijalkowski N, Most SP. Validation of a grading system for lateral nasal wall insufficiency. Allergy Rhinol (Providence). 2013 Summer;4(2):e66-8. doi: 10.2500/ar.2013.4.0054.
- Background: PubMed 26247486Most SP. Comparing Methods for Repair of the External Valve: One More Step Toward a Unified View of Lateral Wall Insufficiency. JAMA Facial Plast Surg. 2015 Sep-Oct;17(5):345-6. doi: 10.1001/jamafacial.2015.0790. No abstract available.
- Individual participant dataSharing planned: No. no plan to share IPD
Related trials for Nasal Valve Incompetence
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction
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.
Sam P Most, MD principal investigator
Stanford 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 Lateral Crural Strut Graft and Bone Anchored Suspension in people with Nasal Valve Incompetence, run by Stanford 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 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: withdrawn, as of the sponsor's last update on 17 Jul 2018. 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?
NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03131115, which also lists 3 linked publications.
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 17 Jul 2018.