NCT00837525

Brief Summary

The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

1.2 years

First QC Date

February 4, 2009

Last Update Submit

February 4, 2009

Conditions

Nasal Valve Collapse

Outcome Measures

Primary Outcomes (1)

  • Nasal obstruction symptom scale

    1 year

Interventions

nasal valve implantPROCEDURE

Injectable implantation of a biodegradable material for support of the Nasal valve.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has nasal valve collapse

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metropolitan ENT and Facial Plastic Surgery

Alexandria, Virginia, 22310, United States

Location

Study Officials

  • Iyad S Saidi, MD PhD

    Metropolitan ENT and Facial Plastic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

US(1)