Condition category
Ear, Nose and Throat
Date applied
17/12/2014
Date assigned
12/01/2015
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lateral nasal wall collapse (collapse of the side of the nose) can cause nasal congestion. The side of the nose (nasal sidewall) collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is a technique used by many surgeons to treat it. It involves anchoring the nasal sidewall to the bony rim below the eye. A recently described technique involves treating the soft tissue of the side of the nose with radiofrequency heat to create a scar that makes the tissue firmer. We want to compare the two treatments to each other. We hope to determine how well the new technique performs in managing lateral nasal wall collapse when compared to one of the standard surgical treatments and also non- surgical treatments. This knowledge could change surgical management as radiofrequency thermotherapy is less invasive, could be performed with only local anesthesia, and does not involve implants - in contrast to the more established bone anchored suture suspension.

Who can participate?
Adults (aged over 18) with nasal obstruction (blockage).

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 are treated using radiofrequency thermotherapy. Those in group 2 are treated using the conventional bone anchored suture suspension technique. Those in group 3 are given non-operative treatments. All patients are assessed for lateral wall insufficiency, nasal obstruction and pain caused by the nasal obstruction before and after treatment.

What are the possible benefits and risks of participating?
Radiofrequency thermotherapy of the lateral nasal wall is a new technique, but radiofrequency treatment itself is well established in the field of otolaryngology (ear, nose and throat specialists) to treat conditions such sleep apnea and other causes of nasal obstruction. Known risks include excess thermal (heat) damage and pain.

Where is the study run from?
Stanford University (USA)

When is the study starting and how long is it expected to run for?
February 2010 to February 2012

Who is funding the study?
1. Stanford University (USA)
2. American Academy of Facial Plastic & Reconstructive Surgery (USA)

Who is the main contact?
Dr Sam Most

Trial website

Contact information

Type

Scientific

Primary contact

Dr. Sam Most

ORCID ID

Contact details

801 Welch Road
Stanford
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRB-18115

Study information

Scientific title

Treatment of lateral nasal wall collapse - a comparison of Bone Anchored SuTure suspension versus Radiofrequency Thermotherapy.

Acronym

BAST vs RF

Study hypothesis

Our hypothesis is that RF will work as well as bone-anchored sutures in treatment of lateral wall insufficiency (LWI).

Ethics approval

Stanford Human Subjects, 2/3/2010, ref: IRB-18115

Study design

This is a single-center, randomized, interventional trial comparing two techniques for treatment of lateral wall insufficiency.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lateral nasal wall collapse is a source of nasal congestion which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose.

Intervention

Bone anchored suture suspension is used by many surgeons to treat lateral wall insufficiency, and involves anchoring the nasal sidewall to the bony rim below the eye. A recently described technique involves treating the sidewall soft tissue with radiofrequency heat to cause scar contraction of the tissue to minimize laxity. We will compare the two treatments to each other, and to non-operative treatment of otherwise surgically-eligible candidates.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Clinician-derived measure of lateral wall insufficiency (LWI score).
2. NOSE (nasal obstruction symptoms evaluation)

Measured at preoperative and postoperative visits.

Secondary outcome measures

1. Visual analog scale for nasal obstruction (VAS)

Measured at preoperative and postoperative visits.

Overall trial start date

01/02/2010

Overall trial end date

28/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy adults with nasal obstruction
2. Over age 18
3. Either gender
4. Any ethnic background

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Children
2. Pregnant women

Recruitment start date

01/02/2010

Recruitment end date

28/02/2012

Locations

Countries of recruitment

United States of America

Trial participating centre

Stanford University
United States of America

Sponsor information

Organisation

Stanford University Department of Otolaryngology

Sponsor details

801 Welch Road
Stanford
94305
United States of America

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Stanford University

Alternative name(s)

SU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United States of America

Funder name

Educational and Research Foundation for the American Academy of Facial Plastic and Reconstructive Surgery

Alternative name(s)

AAFPRS Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Paper accepted by JAMA Facial Plastic Surgery

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25633257

Publication citations

Additional files

Editorial Notes