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Nasal ObstructionNCT02964312

LATERA-OFFICE Study

A study testing Nasal Implant in people with Nasal Obstruction, run by Spirox, Inc. at 9 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

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. 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
166 participants
Where
9 sitesUnited States
Study dates
10 Nov 2016to 29 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 maneuver.
  • 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 an in-office nasal implant procedure alone or with a turbinate reduction procedure.
  • The subject has appropriate nasal and facial anatomy to receive the Latera Implant.
  • The subject agrees to follow-up examinations through 12 months post operatively.
  • The subject has failed to benefit from appropriate maximal medical management [eg, 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 tolerability.

Who cannot join

  • The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty.
  • The subject has had rhinoplasty within the past 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 12 months after the index procedure.
  • The subject has had septoplasty and/or inferior turbinate reduction within the past 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 nonsurgical treatment of their nasal valve, other than the index procedure, within 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 intranasal drug user.
  • The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
  • The subject has polyps or pathology (ie, septal deviation) other than 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 polylactide polymer (PLA) or other absorbable materials.
  • The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could predispose 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 local anesthesia and/or managed anesthesia care (MAC) or conscious sedation.
  • Female subjects of childbearing potential, known or suspected to be pregnant, or is lactating.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • ENT of Georgia

    Atlanta, Georgia, 30342

  • Beverly Hills Aesthetic Surgical Institute

    Beverly Hills, California, 90210

  • Alessi Institute For Facial Plastic Surgery

    Beverly Hills, California, 90212

  • 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

  • Collin County ENT

    Frisco, Texas, 75034

  • Madison ENT & Facial Plastic Surgery

    New York, New York, 10016

  • Ogden Clinic

    Ogden, Utah, 84403

Other trials in United States

About this study

Official title: Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OFFICE) Study

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.

Being tested
Nasal Implant
Keywords
nasal valve collapse, absorbable 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

    Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.

Study groups in NCT02964312
Study groupRoleWhat they receive
Latera ImplantOtherUnilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.
Receives: Device: Nasal Implant

What is being measured

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

  1. 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).

    Measured: 6 months

  2. 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.

    Measured: 6 months

Secondary outcomes (4)

  1. 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).

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

  2. 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.

    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 12 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 posted16 Nov 2016 (estimated)
  2. Study start10 Nov 2016
  3. Primary completion21 Mar 2018
  4. Study completion29 Aug 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
Model description
Single-arm intervention with pre/post comparison for treatment response.
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964312
Sponsor's protocol ID
SPI-CP-302
Status last verified
Aug 2020
First submitted
11 Nov 2016
Last updated
3 Sep 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Sidle DM, Stolovitzky P, Ow RA, Silvers S, Matheny K, Bikhazi N, Wani M, Scurry WC, Most SP. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope. 2020 May;130(5):1132-1137. doi: 10.1002/lary.28151. Epub 2019 Jun 28.

    PubMed 31254279

  • 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 9 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 3 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 9 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 30 Oct 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?

Efficacy: Percent of Treatment Responders (time frame: 6 months). 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 NCT02964312, 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 3 Sep 2020; AzTrials last refreshed its copy on 26 Oct 2026.

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