Nasal Valve CollapseNCT02188589
Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse
A study testing INEX nasal implant in people with Nasal Valve Collapse, run by Spirox, Inc. at 1 site in Germany.
Trial summary
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Valve Collapse
- What is being tested?
- INEX nasal implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Eligible participants are:
- Adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator).
- Nasal valve collapse (NVC) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy.
- Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55.
Participants are excluded for the following:
- Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment.
- Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment.
- Recurrent nasal infections.
- Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation.
- Presence of a permanent implant, dilator, or uses an external device in the nasal area.
- Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study.
- Significant bleeding disorders.
- Significant systemic diseases.
- Currently using nasal oxygen or continuous positive airway pressure (CPAP).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU
Munich, 81377
About this study
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
Read the detailed description
This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
- Conditions
- Nasal Valve Collapse
- Being tested
- INEX nasal implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INEX nasal implantDevice
Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)
| Study group | Role | What they receive |
|---|---|---|
| Nasal implant group | Experimental | Bilateral or unilateral INEX nasal implants Receives: Device: INEX nasal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant-related Adverse Events
Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
Measured: 6 months
Secondary outcomes (2)
Breathing Capacity (NOSE Scores)
Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).
Measured: At baseline and at 6, 12, and 24 months post implant
NOSE Responder Rate
Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.
Measured: At 6, 12, and 24 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionJun 2017
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 (3)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirox, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Berghaus, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188589
- Sponsor's protocol ID
- SPI-NVC-13001
- Status last verified
- Nov 2018
- First submitted
- 4 Jul 2014
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
PubMed 14990910San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7.
PubMed 28388804San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2018 Oct;34(5):545-550. doi: 10.1055/s-0038-1672213. Epub 2018 Sep 18.
PubMed 30227454
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse
- ClinicalTrials.gov ID
- NCT02188589
- Acronym / sponsor ID
- SPI-NVC-13001
- Conditions
- Nasal Valve Collapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Spirox, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Posted 10 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
Detailed description
This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal implant group | Experimental | Device: INEX nasal implantBilateral or unilateral INEX nasal implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| INEX nasal implantTreatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side) | Device | Nasal implant group |
Primary outcome
Implant-related Adverse Events
Time frame: 6 months
Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
2 secondary outcomes
Breathing Capacity (NOSE Scores)
Time frame: At baseline and at 6, 12, and 24 months post implant
NOSE Responder Rate
Time frame: At 6, 12, and 24 months post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14990910Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
- Results publication: PubMed 28388804San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7.
- Results publication: PubMed 30227454San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2018 Oct;34(5):545-550. doi: 10.1055/s-0038-1672213. Epub 2018 Sep 18.
- 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.
Alexander Berghaus, MD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INEX nasal implant in people with Nasal Valve Collapse, run by Spirox, Inc. at 1 site in Germany.
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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 10 Oct 2016). 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?
Implant-related Adverse Events (time frame: 6 months). 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 NCT02188589, which also lists 3 linked publications.
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 26 Mar 2019.