NCT02188589

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 10, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 26, 2019

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

July 4, 2014

Results QC Date

June 17, 2016

Last Update Submit

March 14, 2019

Conditions

Nasal Valve Collapse

Outcome Measures

Primary Outcomes (1)

  • Implant-related Adverse Events

    Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)

    6 months

Secondary Outcomes (2)

  • Breathing Capacity (NOSE Scores)

    At baseline and at 6, 12, and 24 months post implant

  • NOSE Responder Rate

    At 6, 12, and 24 months post implant

Study Arms (1)

Nasal implant group

EXPERIMENTAL

Bilateral or unilateral INEX nasal implants

Device: INEX nasal implant

Interventions

INEX nasal implantDEVICE

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

Nasal implant group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eligible participants are: 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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU

Munich, 81377, Germany

Location

Related Publications (3)

  • Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.

    PMID: 14990910BACKGROUND

  • San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2017 Apr;33(2):233-240. doi: 10.1055/s-0037-1598655. Epub 2017 Apr 7.

    PMID: 28388804RESULT

  • San Nicolo M, Stelter K, Sadick H, Bas M, Berghaus A. A 2-Year Follow-up Study of an Absorbable Implant to Treat Nasal Valve Collapse. Facial Plast Surg. 2018 Oct;34(5):545-550. doi: 10.1055/s-0038-1672213. Epub 2018 Sep 18.

    PMID: 30227454RESULT

Results Point of Contact

Title
Principal Clinical Research & Publications Manager
Organization
Stryker ENT
ellen.omalley@stryker.com
763-463-1598

Study Officials

  • Alexander Berghaus, MD

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 11, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

June 1, 2017

Last Updated

March 26, 2019

Results First Posted

October 10, 2016

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)