Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

NCT00896883

Sinusitis

COMPLETED NA

NewBreez Safety and Efficacy Evaluation

NCT01587664

Swallowing Disorders

TERMINATED NA

Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

NCT00201461

Patent Foramen Ovale Stroke Ischemic Attack, Transient

UNKNOWN PHASE2/PHASE3

Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

NCT05804903

Transcatheter Aortic Valve Implantation

ACTIVE_NOT_RECRUITING NA

Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

NCT05069558

Stroke Patent Foramen Ovale PFO

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Nasal Valve Collapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasal implant group

Bilateral or unilateral INEX nasal implants

Group Type EXPERIMENTAL

INEX nasal implant

Intervention Type DEVICE

Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

INEX nasal implant

Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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).
2. 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.
3. Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55.

Participants are excluded for the following:

1. Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment.
2. Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment.
3. Recurrent nasal infections.
4. Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation.
5. Presence of a permanent implant, dilator, or uses an external device in the nasal area.
6. Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study.
7. Significant bleeding disorders.
8. Significant systemic diseases.
9. Currently using nasal oxygen or continuous positive airway pressure (CPAP).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No