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Nasal ObstructionNCT02952313

Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study

A study testing Nasal Implant in people with Nasal Obstruction, run by Spirox, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasal Obstruction
What is being tested?
Nasal Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
12 sitesUnited States
Study dates
Sep 2016to Aug 2019
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

Who may be able to join

  • The subject has Nasal Obstruction Symptom Evaluation (NOSE) Score ≥55.
  • The subject has dynamic lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver22.
  • The subject is ≥18 years of age.
  • The subject is willing and able to provide informed consent and comply with the study protocol.
  • The subject is seeking treatment for nasal airway obstruction due to Nasal Valve Collapse (NVC) and is willing to undergo nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.
  • The subject has appropriate nasal and facial anatomy to receive Latera Implant.
  • The subject agrees to follow-up examinations through twelve (12) months post operatively.
  • The subject has failed a trial of appropriate maximal medical management [e.g., nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones]. Failure of maximal medical management may be from lack of effectiveness or inability of subject to tolerate.

Who cannot join

  • The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.
  • The subject has had rhinoplasty within the past twelve (12) months.
  • The subject is planning to have other concurrent rhinoplasty procedure.
  • The subject is planning to have other rhinoplasty procedures or will use external dilators within twelve (12) months after the index procedure.
  • The subject has had septoplasty and/or inferior turbinate reduction within the past six (6) months.
  • The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
Show all 20Show fewer
  • The subject plans to have any surgical or non-surgical treatment of their nasal valve, other than the index procedure, within twelve (12) months of the study.
  • The subject has a permanent Implant or dilator in the nasal area.
  • The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
  • The subject currently has active nasal vestibulitis.
  • The subject has a history of nasal vasculitis.
  • The subject is a chronic systemic steroid or recreational intra-nasal drug user.
  • The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
  • The subject has polyps or pathology other than septal deviation and/or turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
  • The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
  • The subject has a known or suspected allergy to poly lactic acid (PLA) or other absorbable materials.
  • The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could pre-dispose the subject to poor wound healing.
  • The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
  • The subject is not a candidate for procedures conducted under general anesthesia, managed anesthesia care (MAC) or conscious sedation.
  • If female, subject is known or suspected to be pregnant or is lactating.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • ENT of Georgia

    Atlanta, Georgia, 30342

  • ENT & Allergy Center of Austin

    Austin, Texas, 78746

  • Beverly Hills Aesthetic Surgical Institute

    Beverly Hills, California, 90210

  • ENT Assoc. of South Florida

    Boca Raton, Florida, 33487

  • The Center for Sinus, Allergy & Sleep Wellness

    Boynton Beach, Florida, 33472

  • Chicago Nasal & Sinus Center

    Chicago, Illinois, 60602

  • Northwestern University

    Chicago, Illinois, 606611

  • Collin County ENT

    Frisco, Texas, 75034

  • ENT New Orelans

    Marrero, Louisiana, 70072

  • Madison ENT & Facial Plastic Surgery

    New York, New York, 10016

  • Ogden Clinic

    Ogden, Utah, 84403

  • Piedmont ENT

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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.

Being tested
Nasal 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.

  • Nasal ImplantDevice

Study groups in NCT02952313
Study groupRoleWhat they receive
Latera ImplantOtherAll participants have unilateral or bilateral placement of LATERA Nasal Implants.
Receives: Device: Nasal Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 months post procedure

  2. Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events

    Number of participants with a device-related or procedure-related adverse event

    Measured: 6 months post procedure

Secondary outcomes (4)

  1. 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).

    Measured: 1, 3 12, 18, and 24 months post procedure.

  2. 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.

    Measured: 1, 3, 6, 12, 18, and 24 months post procedure

  3. 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.

    Measured: 6 months

  4. Procedure and Device Related Adverse Events

    Number of participants who experience procedure or device-related adverse events.

    Measured: After 6 months and up to 24 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionMar 2018
  4. Study completionAug 2019

Resources

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
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952313
Sponsor's protocol ID
SPI-CP-301
Status last verified
Aug 2020
First submitted
31 Oct 2016
Last updated
1 Sep 2020
Data monitoring committee
No
Individual data sharing
No

Publications

  • Stolovitzky P, Sidle DM, Ow RA, Nachlas NE, Most SP. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. 2018 Nov;128(11):2483-2489. doi: 10.1002/lary.27242. Epub 2018 May 14.

    PubMed 29756407

  • Sidle DM, Stolovitzky P, O'Malley EM, Ow RA, Nachlas NE, Silvers S. Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. 2021 Oct;37(5):673-680. doi: 10.1055/s-0041-1726464. Epub 2021 Apr 14.

    PubMed 33853139

Questions about this trial

What is this clinical trial studying?

A study testing Nasal Implant in people with Nasal Obstruction, run by Spirox, Inc. at 12 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?

The sponsor lists 8 inclusion and 20 exclusion criteria. 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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. 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 23 Apr 2019). 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?

The Primary Efficacy Endpoint is the Percent of Treatment Responders (time frame: 6 months post procedure). The study lists 2 primary outcomes in all. 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 NCT02952313, which also lists 2 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 1 Sep 2020.

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