Nasal Valve IncompetenceNCT03793218
Alar Batten Graft vs Latera for Nasal Valve Collapse
A study testing Latera Device and Alar Batten Graft in people with Nasal Valve Incompetence, run by University of Virginia.
Trial summary
Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Valve Incompetence
- What is being tested?
- Latera Device and Alar Batten Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2018to 1 Sep 2019
- 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
- Documented physical exam findings of septal deviation
- Bilateral nasal sidewall collapse on inspiration
- Subjective improvement in nasal obstruction with use of the modified Cottle maneuver
Who cannot join
- Prior septorhinoplasty
- Obvious trauma to the nose causing nasal obstruction
- Inflammatory conditions such as chronic rhinosinusitis with nasal polyposis
- Patients using chronic topical nasal decongestants or illicit intranasal drug use
- Prisoners, cognitively impaired, non-English speaking subjects
About this study
Official title: A Comparison of Alar Batten Graft to the Latera Nasal Implant for the Treatment of Nasal Valve Collapse
Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon. Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage grafting, with alar batten grafting being the most commonly used method to provide support to the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal obstruction. There are several proposed advantages of the implant over traditional operative techniques, namely the ease of endonasal insertion, which can be performed in the outpatient clinic setting. Preliminary investigations demonstrate subjective improvement in nasal obstruction with use of the implant, however, there has been no direct comparison with traditional techniques utilizing cartilage grafting.
This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.
- Conditions
- Nasal Valve Incompetence
- Being tested
- Latera Device, Alar Batten Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latera DeviceDevice
This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant
Alar Batten GraftProcedure or surgery
This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant
| Study group | Role | What they receive |
|---|---|---|
| Latera Device | Experimental | The LATERA (Spirox Inc., Menlo Park, CA) device, an absorbable nasal implant comprised of a 70:30 blend of poly(L-lactide) and poly(D-lactide), is designed to provide support to the upper and lower lateral cartilages, thereby correcting nasal wall collapse. The implant was first used in the US and cleared by the FDA in 2016. It is designed as a ribbed cylindrical structure with a forked distal end. The implant is delivered endonasally, with a 16-gauge catheter, lateral to the upper and lower lateral cartilages and over the ascending process of the maxilla. The forked end rests on the ascending process of the maxilla and the flexible implant provides support the nasal sidewall soft tissue and cartilage. This non-toxic, biocompatible co-polymer has an extensive use in a variety of medical devices including suture materials and implants. In vivo studies demonstrate the copolymer to reliably decompose over an 18-24 month period. Receives: Device: Latera Device |
| Alar Batten Graft | Active comparator | This study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant Receives: Procedure: Alar Batten Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 Month NOSE Score
Mean change in Nose score at 12 month post-op visit
Measured: 12 months
Secondary outcomes (3)
1 Month NOSE Score
Mean change in Nose score at 1 month post-op visit
Measured: 1 month
6 Month NOSE Score
Mean change in Nose score at 6 month post-op visit
Measured: 6 months
24 Month NOSE Score
Mean change in Nose score at 24 month post-op visit
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start28 Aug 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: PI left institution before participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Valve IncompetenceStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Portland VA Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793218
- Sponsor's protocol ID
- 20859
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2019
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Alar Batten Graft to the Latera Nasal Implant for the Treatment of Nasal Valve Collapse
- ClinicalTrials.gov ID
- NCT03793218
- Acronym / sponsor ID
- 20859
- Conditions
- Nasal Valve Incompetence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution before participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Portland VA Medical Center
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 4 Jan 2019 (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.
Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon. Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage grafting, with alar batten grafting being the most commonly used method to provide support to the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal obstruction. There are several proposed advantages of the implant over traditional operative techniques, namely the ease of endonasal insertion, which can be performed in the outpatient clinic setting. Preliminary investigations demonstrate subjective improvement in nasal obstruction with use of the implant, however, there has been no direct comparison with traditional techniques utilizing cartilage grafting.
This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Latera Device | Experimental | Device: Latera DeviceThe LATERA (Spirox Inc., Menlo Park, CA) device, an absorbable nasal implant comprised of a 70:30 blend of poly(L-lactide) and poly(D-lactide), is designed to provide support to the upper and lower lateral cartilages, thereby correcting nasal wall collapse. The implant was first used in the US and cleared by the FDA in 2016. It is designed as a ribbed cylindrical structure with a forked distal end. The implant is delivered endonasally, with a 16-gauge catheter, lateral to the upper and lower lateral cartilages and over the ascending process of the maxilla. The forked end rests on the ascending process of the maxilla and the flexible implant provides support the nasal sidewall soft tissue and cartilage. This non-toxic, biocompatible co-polymer has an extensive use in a variety of medical devices including suture materials and implants. In vivo studies demonstrate the copolymer to reliably decompose over an 18-24 month period. |
| Alar Batten Graft | Active comparator | Procedure: Alar Batten GraftThis study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented physical exam findings of septal deviation
- Bilateral nasal sidewall collapse on inspiration
- Subjective improvement in nasal obstruction with use of the modified Cottle maneuver
Key exclusion criteria (5 listed)
- Prior septorhinoplasty
- Obvious trauma to the nose causing nasal obstruction
- Inflammatory conditions such as chronic rhinosinusitis with nasal polyposis
- Patients using chronic topical nasal decongestants or illicit intranasal drug use
- Prisoners, cognitively impaired, non-English speaking subjects
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 |
|---|---|---|
| Latera DeviceThis study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant | Device | Latera Device |
| Alar Batten GraftThis study seeks to compare a "gold standard" functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant | Procedure or surgery | Alar Batten Graft |
Primary outcome
12 Month NOSE Score
Time frame: 12 months
Mean change in Nose score at 12 month post-op visit
3 secondary outcomes
1 Month NOSE Score
Time frame: 1 month
6 Month NOSE Score
Time frame: 6 months
24 Month NOSE Score
Time frame: 24 months
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 11 Jan 2024.
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"
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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?
A study testing Latera Device and Alar Batten Graft in people with Nasal Valve Incompetence, run by University of Virginia.
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 3 inclusion and 5 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 11 Jan 2024. 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?
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?
12 Month NOSE Score (time frame: 12 months). 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 11 Jan 2024.