An interventional study of Nasal Implant in Nasal Obstruction, sponsored by Spirox, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.
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 11th 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 29th 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 166 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.
Prospective, multicenter, nonrandomized, single-arm controlled study to obtain outcomes data in participants with severe to extreme class NOSE scores who are undergoing placement of the Spirox Latera Implant with or without concurrent turbinate reduction procedures in an office 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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.
Device: Nasal Implant
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
Efficacy: Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time frame: 6 months
Safety: Procedure- and/or Device-related Adverse Events
Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
Time frame: 6 months
Percent of Treatment Responders
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Time frame: 1, 3, 12, 18, and 24 months post procedure.
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values 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 12 months post procedure
| Milestone | Latera Implant |
|---|---|
| Started | 166 |
| 1-month follow-up | 164 |
| 3-month follow-up | 159 |
| 6-month follow-up | 152 |
| 12-month follow-up | 139 |
| 18-month follow-up | 112 |
| 24-month follow-up | 102 |
| Completed | 102 |
| Not completed | 64 |
| Withdrew: Lost to follow-up | 28 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Lack of efficacy | 10 |
| Withdrew: Did not consent to long-term fu | 14 |
| Withdrew: Death | 1 |
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
| Participants | Latera Implant |
|---|---|
| Efficacy: Percent of Treatment Responders | 136 |
Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
| Participants | Latera Implant |
|---|---|
| Safety: Procedure- and/or Device-related Adverse Events | 31 |
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
| Participants | Latera Implant |
|---|---|
| 1-Month Follow-up | 147 |
| 3-Month Follow-up | 143 |
| 12-Month Follow-up | 124 |
| 18-Month Follow-up | 103 |
| 24-Month Follow-up | 93 |
Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values indicate improvement in symptoms.
| score on a scale | Latera Implant |
|---|---|
| 1-Month Follow-up | -34.3 ± 27.0 |
| 3-Month Follow-up | -35.5 ± 28.5 |
| 6-Month Follow-up | -36.9 ± 29.0 |
| 12-Month Follow-up | -37.9 ± 29.8 |
| 18-Month Follow-up | -41.5 ± 27.3 |
| 24-Month Follow-up | -41.7 ± 26.8 |
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 | 115 |
Number of participants who experience procedure- or device-related adverse events.
| Participants | Latera Implant |
|---|---|
| Procedure and Device-related Adverse Events | 3 |
Collected over 24 months post procedure. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Latera Implant | 1/166 (0.6%) | 0/166 (0%) | 24/166 (14.5%) |
| Event | Latera Implant |
|---|---|
| Implant migration/retrievalSurgical and medical procedures | 15/166 |
| Sinus infectionInfections and infestations | 10/166 |
All participants enrolled and treated with the Latera Implant.
| Age, Continuous(years) | Latera Implant |
|---|---|
| Mean | 50.5 ± 14.9 |
| Sex: Female, Male(Participants) | Latera Implant |
|---|---|
| Female | 82 |
| Male | 84 |
| Race/Ethnicity, Customized(Participants) | Latera Implant |
|---|---|
| Race — American Indian or Alaska Native | 1 |
| Race — Asian | 3 |
| Race — Black or African American | 3 |
| Race — Hispanic or Latino | 11 |
| Race — White | 143 |
| Race — Other | 4 |
| Race — Not Specified | 1 |
| Region of Enrollment(participants) | Latera Implant |
|---|---|
| United States | 166 |
| NOSE score (100-point scale)(units on a scale) | Latera Implant |
|---|---|
| Mean | 77.4 ± 13.4 |
| Nose Severity Class(Participants) | Latera Implant |
|---|---|
| Severe | 90 |
| Extreme | 76 |
| Nasal Obstruction Visual Analog Scale (VAS)(units on a scale) | Latera Implant |
|---|---|
| Mean | 68.0 ± 18.0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2016 to primary completion in Mar 2018, 16 months.
Results were first posted in Oct 2019, 1 year 7 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 16 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 Aug 2020. You cannot join it, but the record below documents what was studied.
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