CompletedNot Applicable

LATERA-OFFICE Study

United States166 participantsStarted 2016-11-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

Efficacy: Percent of Treatment Responders

Timeframe: 6 months

Safety: Procedure- and/or Device-related Adverse Events

Timeframe: 6 months

Trial details

NCT IDNCT02964312

SponsorSpirox, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-21

Results submitted2019-10-09

View on ClinicalTrials.gov More Nasal Obstruction trials