An interventional study of Latera Implant and Sham Procedure in Nasal Valve Collapse and Nasal Breathing, sponsored by Spirox, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Spirox, Inc. (part of Stryker) · Not applicable, Interventional, and Treatment
Among 65 studies in Nasal Obstruction with a site in United States — 9 open to participants now, 11 under way, 1 of them phase 3. Nasal Obstruction · United States.
Among the 65 studies in Nasal Obstruction with a site in United States, this one is the 14th largest by enrollment of the 56 interventional ones that give a count, is one of 4 that started in 2017, is one of 34 with no phase, and was the 33rd registered.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
Browse Nasal Obstruction studies →9 of the 65 studies in Nasal Obstruction with a site in United States are open now. Recruiting first, the newest first:
Aerin Medical · Sites in United States
Ages 22–85
Washington University School of Medicine · Sites in United States
Ages 18+
Ohio State University · Sites in United States
Ages 18–70 · Healthy volunteers
University of Michigan · Sites in United States
Ages 3–21
Endeavor Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 20 Nasal Obstruction studies recruiting now, 7 (35%) set no upper age limit and 11 (55%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
65 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 11 · Phase 3 8 · Phase 4 4
First in 2005; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 137 is above the median of 70 across 139 interventional studies indexed under Nasal Obstruction.
Median enrollment 51 across the 56 interventional studies, 40 across the 9 observational. Of the 50 that completed or were terminated, 27 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 65 have an industry lead sponsor. The 10 most frequent:
This study is registered under Spirox, Inc., one of the names counted as Stryker. Under that name alone:
Spirox, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Stryker has 3 studies filed under Nasal Obstruction — fewer than ten, so there is no comparison to draw.
7 of the studies in Nasal Obstruction with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04194216Phase 3Stanford UniversityAntibiotic Prophylaxis in Rhinoplasty | 2026-12-20 |
| NCT06830109Washington University School of MedicineNasal Obstruction With Oxymetazoline and Corticosteroids | 2026-12-30 |
| NCT06163404Spirair, IncOpen-Label Study to Evaluate the Safety and Effectiveness of the Spirair Implant | 2027-03 |
| NCT07574918Aerin MedicalMeasuring Nasal Airway Changes After VivAer Treatment Using AI Analysis | 2027-05 |
| NCT05527652University of MichiganSelf-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia | 2027-05 |
Add all 7 to your calendar (.ics) → With an account.
Among the 65 studies in Nasal Obstruction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Subjects must meet the following criteria to be included in the study:
Subjects meeting any one of the following criteria will be excluded for the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Latera Implant
Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.
Device: Sham Procedure
Treatment with implant
Sham procedure where the Latera delivery device is inserted but no implant delivered.
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.
Time frame: 3 months postprocedure.
Responder Rate
Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed
Time frame: 7 days, 30 days, and 6, 12, 18 and 24 months.
| Milestone | Sham Control Arm | Latera Treatment Arm |
|---|---|---|
| Started | 66 | 71 |
| 3-month follow-up | 64 | 63 |
| Completed | 64 | 63 |
| Not completed | 2 | 8 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Unblinded before 3-month follow-upa- | 0 | 6 |
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.
| Participants | Sham Control Arm | Latera Treatment Arm |
|---|---|---|
| NOSE Responder Rate | 35 | 52 |
Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed
Results for this outcome have not been posted.
Collected over Adverse events reported from procedure through 3-month follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham Control Arm | 1/64 (1.6%) | 2/64 (3.1%) | 0/64 (0%) |
| Latera Treatment Arm | 0/63 (0%) | 3/63 (4.8%) | 5/63 (7.9%) |
| Event | Sham Control Arm | Latera Treatment Arm |
|---|---|---|
| Liver cancerHepatobiliary disorders | 0/64 | 1/63 |
| Degenerative disc disease/stenosisMusculoskeletal and connective tissue disorders | 0/64 | 1/63 |
| Severe hypertensionGeneral disorders | 0/64 | 1/63 |
| DeathGeneral disorders | 1/64 | 0/63 |
| Orthopedic surgeryMusculoskeletal and connective tissue disorders | 1/64 | 0/63 |
| Event | Sham Control Arm | Latera Treatment Arm |
|---|---|---|
| Implant extrusion/migrationProduct Issues | 0/64 | 5/63 |
Participants with evaluable data for the primary endpoint at 3-month follow-up
| Age, Continuous(years) | Sham Control Arm | Latera Treatment Arm | Total |
|---|---|---|---|
| Mean | 51.3 ± 13.5 | 50.9 ± 14.2 | 51.1 ± 13.8 |
| Sex: Female, Male(Participants) | Sham Control Arm | Latera Treatment Arm | Total |
|---|---|---|---|
| Female | 40 | 37 | 77 |
| Male | 24 | 26 | 50 |
| Race (NIH/OMB)(Participants) | Sham Control Arm | Latera Treatment Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 5 | 2 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 51 | 58 | 109 |
| More than one race | 4 | 2 | 6 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Sham Control Arm | Latera Treatment Arm | Total |
|---|---|---|---|
| United States | 64 | 63 | 127 |
| Baseline Nasal Obstruction Symptom Evaluation (NOSE) Score(units on a scale) | Sham Control Arm | Latera Treatment Arm | Total |
|---|---|---|---|
| Mean | 77.7 ± 15.1 | 77.4 ± 13.1 | 77.6 ± 14.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Feb 2019, 14 months.
Results were first posted in Jan 2020, 11 months after primary completion.
Of 60 interventional studies with no phase under Nasal Obstruction, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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