An interventional study of Nasal Implant in Nasal Obstruction, sponsored by Spirox, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-01.
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 20th largest by enrollment of the 56 interventional ones that give a count, is one of 5 that started in 2016, is one of 34 with no phase, and was the 28th 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 · no healthy volunteers.
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. 5 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 113 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.
This study is being conducted to obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing placement of the Spirox Latera Implant with or without concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Device: Nasal Implant
The Primary Efficacy Endpoint is the Percent of Treatment Responders
Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
Time frame: 6 months post procedure
Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
Number of participants with a device-related or procedure-related adverse event
Time frame: 6 months post procedure
Percent of Treatment Responders
Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
Time frame: 1, 3 12, 18, and 24 months post procedure.
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).
Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose). Negative values for the change from baseline indicate improvement in symptoms.
Time frame: 1, 3, 6, 12, 18, and 24 months post procedure
Subject Satisfaction Questionnaire
Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.
Time frame: 6 months
Procedure and Device Related Adverse Events
Number of participants who experience procedure or device-related adverse events.
Time frame: After 6 months and up to 24 months post procedure
| Milestone | Latera Implant |
|---|---|
| Started | 113 |
| 6 months | 106 |
| Completed | 106 |
| Not completed | 7 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Missed visit | 1 |
| Milestone | Latera Implant |
|---|---|
| Started | 107 |
| 12-month | 93 |
| 18-month | 79 |
| Completed | 75 |
| Not completed | 32 |
| Withdrew: Lost to follow-up | 12 |
| Withdrew: Did not reconsent for long-term fu | 7 |
| Withdrew: Lack of efficacy | 6 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Physician decision | 1 |
| Withdrew: Death | 1 |
Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
| Participants | Latera Implant |
|---|---|
| The Primary Efficacy Endpoint is the Percent of Treatment Responders | 101 |
Number of participants with a device-related or procedure-related adverse event
| Participants | Latera Implant |
|---|---|
| Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events | 10 |
Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
| Participants | Latera Implant |
|---|---|
| 1-Month FU | 104 |
| 3-Month FU | 106 |
| 12-Month FU | 88 |
| 18-Month FU | 70 |
| 24-Month FU | 72 |
Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose). Negative values for the change from baseline indicate improvement in symptoms.
| score on a scale | Latera Implant |
|---|---|
| 1-Month FU | -40.4 (-44.4 to -36.4) |
| 3-Month FU | -46.3 (-50.3 to -42.3) |
| 6-Month FU | -45.6 (-49.7 to -41.5) |
| 12-Month FU | -47.5 (-51.9 to -43.1) |
| 18-Month FU | -48.7 (-53.6 to -43.8) |
| 24-Month FU | -51.0 (-55.9 to -46.2) |
Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.
| Participants | Latera Implant |
|---|---|
| Subject Satisfaction Questionnaire | 89 |
Number of participants who experience procedure or device-related adverse events.
| Participants | Latera Implant |
|---|---|
| Procedure and Device Related Adverse Events | 1 |
Collected over Adverse events for the primary safety endpoint are reported for the 6-month period after the study procedure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Latera Implant | 1/113 (0.9%) | 2/113 (1.8%) | 19/113 (16.8%) |
| Event | Latera Implant |
|---|---|
| Gastrointestinal bleedGastrointestinal disorders | 1/113 |
| Heart valve diseaseCardiac disorders | 1/113 |
| Event | Latera Implant |
|---|---|
| SinusitisInfections and infestations | 13/113 |
| Implant retrieval/extrusionSurgical and medical procedures | 7/113 |
| Age, Continuous(years) | Latera Implant |
|---|---|
| Mean | 45.3 ± 13.7 |
| Sex: Female, Male(Participants) | Latera Implant |
|---|---|
| Female | 49 |
| Male | 64 |
| Race/Ethnicity, Customized(Participants) | Latera Implant |
|---|---|
| Ethnicity — Non-Hispanic or Latino | 102 |
| Ethnicity — Hispanic or Latino | 10 |
| Ethnicity — Unspecified | 1 |
| Region of Enrollment(Participants) | Latera Implant |
|---|---|
| United States | 113 |
| NOSE Score (100-point scale)(units on a scale) | Latera Implant |
|---|---|
| Mean | 78.5 ± 13.8 |
| NOSE Severity Classification(Participants) | Latera Implant |
|---|---|
| Severe (NOSE Scores of 55-75) | 56 |
| Extreme (Nose Scores of 80-100 | 57 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2016 to primary completion in Mar 2018, 18 months.
Results were first posted in Apr 2019, 1 year 1 month 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 18 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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