What side effects are associated with this type of intervention?

Treatments for nasal obstruction, particularly those involving surgical interventions like bioabsorbable implants for septal deviation, can have side effects such as infection, bleeding, and postoperative pain. Non-surgical treatments, including nasal corticosteroids and decongestants, may cause nasal irritation, dryness, and systemic effects with long-term use. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for nasal obstruction, including bioabsorbable implants designed to provide structural support and correct septal deviation. One such example is the Propel sinus implant, which is used post-surgery to maintain sinus patency and deliver localized steroid therapy. These implants are designed to be absorbed by the body over time, reducing the need for additional surgical interventions. Other treatments include traditional septoplasty and the use of silicone stents, although these do not offer the same bioabsorbable benefits.

What other types of research exist?

Promising novel alternatives to bioabsorbable implants for nasal obstruction patients include endobronchial valve therapy and sublingual immunotherapy (SLIT). Endobronchial valve therapy, typically used for emphysema, has shown potential in improving airflow and could be adapted for nasal obstruction. SLIT, primarily used for allergic rhinitis, offers a non-invasive approach to managing nasal obstruction by reducing allergic inflammation and improving nasal airflow.

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Procedure

Spirair Implant for Deviated Septum

Verified Trial

N/A

Recruiting

Research Sponsored by Spirair, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥21 to ≤ 64 years of age at time of consent

Seeking treatment for nasal airway obstruction (NAO) symptoms due primarily to cartilaginous nasal septal deviation

Must not have

History of a significant bleeding disorder(s) and/or taking current prescription blood thinner medication

Target nasal septal deviation that is calcified or non-mobile

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Spirair Implant, which helps straighten a crooked nasal septum. The implant is designed to be absorbed by the body over time. It aims to improve breathing and correct the shape of the septum in patients with this condition.

Who is the study for?

Adults aged 21-64 with a deviated septum causing nasal blockage, who are seeking treatment and willing to undergo an implant procedure. Participants must have significant symptoms (NOSE score ≥30), speak English, and be able to follow the study protocol. Excluded are those with prior nose surgeries, concurrent ENT procedures other than turbinate reduction, certain nasal deformities or conditions, active infections at the site of implantation, recent drug abuse history, pregnant or breastfeeding women, and anyone unable to comply with the study requirements.

What is being tested?

The trial is testing a new bioabsorbable Spirair Nasal Device implanted using a special delivery system designed for people with nasal airway obstruction due to septal deviation. It's an open-label pilot study which means everyone gets the device and knows what they're receiving.

What are the potential side effects?

Potential side effects may include local reactions at the implant site like swelling or infection, discomfort from the procedure itself, possible allergic reactions if sensitive to materials in the device such as poly(dioxanone), and complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 64 years old.

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I am looking for treatment because my nose is blocked due to a bent nasal septum.

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I am willing to have a nasal implant procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder or am on prescription blood thinners.

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My nasal septum deviation is hard or doesn't move.

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I have had nose surgery in the past.

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I am having an ENT procedure that is not turbinate reduction.

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I have not had a turbinate reduction in the last 6 months.

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I do not have an infection where my implant will be placed.

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I use steroids regularly or have used drugs through the nose.

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I do not have major health issues that could affect my healing or study results.

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I have smoked or used tobacco products within the last year.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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I am not in, nor plan to join, another clinical trial or have other nasal treatments while in this study.

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I am taking prescription painkillers.

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I have a noticeable dip in the bridge of my nose.

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I have had issues with nasal inflammation, unhealed wounds, or nose structure problems.

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My nasal septum is severely deviated, blocking view of the middle meatus.

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I have symptoms like a runny nose or sneezing.

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I have an infection at the site where I would receive treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary study objectives

Secondary Endpoint - 1

Secondary Endpoint - 2

Secondary Endpoint - 3

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational DeviceExperimental Treatment1 Intervention

Treatment with the Spirair Septal correction device and delivery system for correction of cartilaginous nasal septal deviation.

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for nasal obstruction, such as bioabsorbable implants, work by providing structural support to correct anatomical issues like septal deviation. These implants temporarily support the nasal septum, allowing it to heal in a corrected position before being absorbed by the body. This mechanism is crucial for nasal obstruction patients as it addresses the root cause of the obstruction, offering a potential long-term solution without the need for permanent implants or repeated surgeries.