Nasal Valve CollapseNCT03400787
Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse
A study testing Latera Implant in people with Nasal Valve Collapse and Nasal Breathing, run by Spirox, Inc. at 11 sites in United States.
Trial summary
The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure. 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, Nasal Breathing
- What is being tested?
- Latera Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Nov 2017to 23 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Subjects must meet the following criteria to be included in the study:
- Adults aged 18 and above;
- Understands and provides written informed consent;
- Stated willingness to comply with all study procedures, post-treatment care and availability for the duration of the study follow up of 2 years;
- In good general health as evidenced by medical history;
- NOSE score ≥55;
- Dynamic bi-lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver;
- Nasal and facial anatomy appropriate to receive the Latera Implant;
- Documented failure of benefit after at least 4 weeks of conservative medical management, including, for example, antihistamines or nasal steroids, evidenced by lack of efficacy or tolerability.
Subjects meeting any one of the following criteria will be excluded for the study:
- Unable to tolerate or not a candidate for procedures performed under local anesthesia;
- Pathology other than lateral wall insufficiency (e.g. septal deviation, turbinate or adenoid hypertrophy, polyps, sinusitis, rhinitis) is the primary contributor to airway obstruction;
- Requires or is anticipated to require any other concurrent nasal procedures (e.g. Functional Endoscopic Sinus Surgery (FESS), rhinoplasty, sinuplasty, septoplasty, or turbinate reduction) outside of the index procedure within 12 months after the index procedure;
- FESS, sinuplasty, septoplasty, inferior turbinate reduction, or rhinoplasty within the past 6 months;
- Any other rhinoplasty procedures are planned or planned usage of external dilators within 24 months after the index procedure;
- Permanent nasal implant of any type (e.g. autologous, homologous, or synthetic graft) or dilator;
- Presence of concomitant inflammatory or infectious conditions or unhealed wounds in the treatment area (e.g., vestibulitis, vasculitis, active acne),
- Currently using chronic systemic steroids or recreational intra-nasal drugs;
- Currently has cancerous or pre-cancerous nasal lesions, has had radiation in the treatment area, or is currently receiving chemotherapy;
- History of a significant healing disorders including hypertrophic scarring, or keloid formation;
- Poorly controlled diabetes mellitus;
- Known or suspected allergy to PLA or other absorbable implant materials in the Latera Implant;
- Severe obstructive sleep apnea (OSA) and cannot or is unwilling to refrain from continuous positive airway pressure (CPAP) for up to 2 weeks post-procedure based on expected healing needs and mask types, in agreement with the treating physician;
- Female subjects, of child bearing potential, known or suspected to be pregnant or are lactating;
- Any other presenting condition that, in the medical opinion of the investigator, would disqualify the subject from the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Albany ENT & Allergy
Albany, New York, 12206
ENT of GA
Atlanta, Georgia, 30342
Chicago Nasal and Sinus Center
Chicago, Illinois, 60602
Texas ENT Specialist
Houston, Texas, 77094
ENT Associates of Texas
McKinney, Texas, 78209
Ogden Clinic
Ogden, Utah, 84403
Sacramento ENT
Roseville, California, 95661
Texas Facial Plastics and ENT
San Antonio, Texas, 78239
Michiana Sleep and ENT Solutions
South Bend, Indiana, 46635
Breathe Clear Institute
Torrance, California, 90503
Piedmont ENT
Winston-Salem, North Carolina, 27103
About this study
Official title: Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse
The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.
Read the detailed description
To evaluate the Latera Absorbable Nasal Implant (Latera Implant) Implant versus Sham Control in subjects with nasal valve collapse due to or primarily due to insufficient cartilaginous support of the lateral nasal wall.
- Conditions
- Nasal Valve Collapse, Nasal Breathing
- Being tested
- Latera Implant, Sham Procedure
- Keywords
- nasal airway obstruction, sham-control, Polylactide absorbable implant
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latera ImplantDevice
Treatment with implant
Sham ProcedureDevice
Sham procedure where the Latera delivery device is inserted but no implant delivered.
| Study group | Role | What they receive |
|---|---|---|
| Sham Control Arm | Sham comparator | Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed.
Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study. Receives: Device: Latera Implant |
| Latera Treatment Arm | Experimental | Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant. Receives: Device: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
NOSE Responder Rate
The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction.
Measured: 3 months postprocedure.
Secondary outcomes (1)
Responder Rate
Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed
Measured: 7 days, 30 days, and 6, 12, 18 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start28 Nov 2017
- Primary completion1 Feb 2019
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Sham procedure participants will be allowed to crossover to receive Latera implants after the 3-month assessment if they continue to meet eligibility criteria. Crossover participants will be followed through 24 months post implant. Sham participants who do not crossover will be exited after the 3-month assessment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirox, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Arch Consulting
- Responsible party
- Sponsor
- Investigators
- Pablo Stolovitzky, MD, Principal investigator, ENT of GeorgiaDouglas Sidle, MD, Principal investigator, Northwestern Facial Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400787
- Sponsor's protocol ID
- CP 04
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2018
- Last updated
- 9 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stolovitzky P, Senior B, Ow RA, Mehendale N, Bikhazi N, Sidle DM. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol. 2019 Aug;9(8):850-856. doi: 10.1002/alr.22362. Epub 2019 Jun 21.
PubMed 31226238
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latera Randomized Controlled Trial (RCT) - Latera® Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse
- ClinicalTrials.gov ID
- NCT03400787
- Acronym / sponsor ID
- CP 04
- Conditions
- Nasal Valve Collapse, Nasal Breathing
- Keywords
- nasal airway obstruction, sham-control, Polylactide absorbable implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Spirox, Inc.Industry (pharma, biotech, devices)
- Collaborators
- New Arch Consulting
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.
Detailed description
To evaluate the Latera Absorbable Nasal Implant (Latera Implant) Implant versus Sham Control in subjects with nasal valve collapse due to or primarily due to insufficient cartilaginous support of the lateral nasal wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Sham procedure participants will be allowed to crossover to receive Latera implants after the 3-month assessment if they continue to meet eligibility criteria. Crossover participants will be followed through 24 months post implant. Sham participants who do not crossover will be exited after the 3-month assessment.
| Arm | Type | Receives |
|---|---|---|
| Sham Control Arm | Sham comparator | Device: Latera ImplantSubjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study. |
| Latera Treatment Arm | Experimental | Device: Sham ProcedureSubjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 ImplantTreatment with implant | Device | Sham Control Arm |
| Sham ProcedureSham procedure where the Latera delivery device is inserted but no implant delivered. | Device | Latera Treatment Arm |
Primary outcome
NOSE Responder Rate
Time frame: 3 months postprocedure.
The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction.
1 secondary outcome
Responder Rate
Time frame: 7 days, 30 days, and 6, 12, 18 and 24 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31226238Stolovitzky P, Senior B, Ow RA, Mehendale N, Bikhazi N, Sidle DM. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol. 2019 Aug;9(8):850-856. doi: 10.1002/alr.22362. Epub 2019 Jun 21.
- Individual participant dataSharing planned: No
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.
Pablo Stolovitzky, MD principal investigator
ENT of Georgia
Douglas Sidle, MD principal investigator
Northwestern Facial Plastic Surgery
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latera Implant in people with Nasal Valve Collapse and Nasal Breathing, run by Spirox, Inc. at 11 sites 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?
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: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Responder Rate (time frame: 3 months postprocedure.). 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 NCT03400787, which also lists 1 linked publication.
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 9 Feb 2021.