Evaluation of an Absorbable Implant for the Treatment of Nasal Valve

Clinical Trial Description

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. ;

Study Design

See also
Status	Clinical Trial	Phase
Completed	`NCT03400787` - Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse	N/A
Enrolling by invitation	`NCT00837525` - Validity Study of a Nasal Valve Implant	N/A
Recruiting	`NCT05287841` - Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?	N/A

See also

Status

Clinical Trial

Phase

Completed

NCT03400787 - Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse

N/A

Enrolling by invitation

NCT00837525 - Validity Study of a Nasal Valve Implant

N/A

Recruiting

NCT05287841 - Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02188589
Study type	Interventional
Source	Spirox, Inc.
Contact
Status	Completed
Phase	N/A
Start date	April 2014
Completion date	June 2017

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms