NCT00358267

Brief Summary

Turbinates are large structures in the nasal airway that help the nose to clean and humidify the air we breathe. Inferior turbinates can swell up and block the breathing passage, making it hard to breath. To address this, turbinate size must be reduced. This study looks at two common procedures for turbinate reduction:

  1. 1.Radiofrequency Ablation (RFA) involves inserting a special needle into the inferior (lower) turbinate that releases thermal energy, which significantly reduces its size. This can be done under local anesthesia at the doctor's office.
  2. 2.Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a piece off the turbinate, which also reduces its size.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

2.7 years

First QC Date

July 27, 2006

Last Update Submit

February 24, 2016

Conditions

Nasal ObstructionSeptal DeformityTurbinate Hypertrophy

Keywords

Inferior Turbinate ReductionPartial Resection of Inferior Turbinates (PRIT)Radiofrequency Ablation (RFA)NOSE scaleNasal Obstruction

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint for the 80 subjects enrolled will be the NOSE Score at 12 months.

    12 months

Secondary Outcomes (1)

  • The prevalence of complications.

    12 months

Study Arms (2)

RFA

ACTIVE COMPARATOR

Radiofrequency Ablation (RFA) involves inserting a special needle into the inferior (lower) turbinate that releases high frequency energy, which produces heat. The energy and heat cause tissue denaturation (protein damage) and vaporization. The vaporization reduces tissue volume, and denaturation causes healing with scar tissue formation and contraction of surrounding tissue. This procedure can be done under local anesthesia at the doctor's office.

Procedure: Radiofrequency Ablation (RFA)

PRIT

ACTIVE COMPARATOR

Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a small piece off the turbinate, which also reduces its size.

Procedure: Partial Resection of Inferior Turbinates (PRIT)

Interventions

Partial Resection of Inferior Turbinates (PRIT)PROCEDURE

PRIT involves surgically removing a small piece off the turbinate, which also reduces its size.

PRIT
Radiofrequency Ablation (RFA)PROCEDURE

RFA involves inserting a special needle into the inferior (lower) turbinate that releases high frequency energy, which produces heat. The energy and heat cause tissue denaturation (protein damage) and vaporization. The vaporization reduces tissue volume, and denaturation causes healing with scar tissue formation and contraction of surrounding tissue. This procedure can be done under local anesthesia at the doctor's office.

RFA

Eligibility Criteria

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

You may qualify if:

  • Study subjects will be male or female, 18 years or older, with nasal septal deformity and bilateral inferior turbinate hypertrophy

You may not qualify if:

  • Subjects with contraindication to general anesthesia or nasal surgery
  • Additional simultaneous nasal surgery, such as sinus surgery or rhinoplasty
  • Nasal polyposis and prior inferior turbinectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (11)

  • Nease CJ, Krempl GA. Radiofrequency treatment of turbinate hypertrophy: a randomized, blinded, placebo-controlled clinical trial. Otolaryngol Head Neck Surg. 2004 Mar;130(3):291-9. doi: 10.1016/j.otohns.2003.11.003.

    PMID: 15054369BACKGROUND

  • Bhattacharyya N, Kepnes LJ. Clinical effectiveness of coblation inferior turbinate reduction. Otolaryngol Head Neck Surg. 2003 Oct;129(4):365-71. doi: 10.1016/S0194-59980300634-X.

    PMID: 14574290BACKGROUND

  • Grymer LF, Illum P, Hilberg O. Septoplasty and compensatory inferior turbinate hypertrophy: a randomized study evaluated by acoustic rhinometry. J Laryngol Otol. 1993 May;107(5):413-7. doi: 10.1017/s0022215100123308.

    PMID: 8326220BACKGROUND

  • Ophir D, Schindel D, Halperin D, Marshak G. Long-term follow-up of the effectiveness and safety of inferior turbinectomy. Plast Reconstr Surg. 1992 Dec;90(6):980-4; discussion 985-7.

    PMID: 1448533BACKGROUND

  • Moore GF, Freeman TJ, Ogren FP, Yonkers AJ. Extended follow-up of total inferior turbinate resection for relief of chronic nasal obstruction. Laryngoscope. 1985 Sep;95(9 Pt 1):1095-9.

    PMID: 4033334BACKGROUND

  • Fanous N. Anterior turbinectomy. A new surgical approach to turbinate hypertrophy: a review of 220 cases. Arch Otolaryngol Head Neck Surg. 1986 Aug;112(8):850-2. doi: 10.1001/archotol.1986.03780080050010.

    PMID: 3718689BACKGROUND

  • Moore EJ, Kern EB. Atrophic rhinitis: a review of 242 cases. Am J Rhinol. 2001 Nov-Dec;15(6):355-61.

    PMID: 11777241BACKGROUND

  • Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.

    PMID: 15054368BACKGROUND

  • 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

  • Utley DS, Goode RL, Hakim I. Radiofrequency energy tissue ablation for the treatment of nasal obstruction secondary to turbinate hypertrophy. Laryngoscope. 1999 May;109(5):683-6. doi: 10.1097/00005537-199905000-00001.

    PMID: 10334213BACKGROUND

  • Li KK, Powell NB, Riley RW, Troell RJ, Guilleminault C. Radiofrequency volumetric tissue reduction for treatment of turbinate hypertrophy: a pilot study. Otolaryngol Head Neck Surg. 1998 Dec;119(6):569-73. doi: 10.1016/S0194-5998(98)70013-0.

    PMID: 9852527BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Michael G Stewart, MD, MPH

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 31, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

US(1)