Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-31 @ 9:26 AM
Study NCT ID:
NCT00358267
Status:
WITHDRAWN
Last Update Posted:
2016-02-26
First Post:
2006-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial Comparing Partial Resection of Inferior Turbinate(PRIT) and Radiofrequency Ablation(RFA) for Inferior Turbinate Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2006-07-27', 'studyFirstSubmitQcDate': '2006-07-27', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint for the 80 subjects enrolled will be the NOSE Score at 12 months.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'The prevalence of complications.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['Inferior Turbinate Reduction', 'Partial Resection of Inferior Turbinates (PRIT)', 'Radiofrequency Ablation (RFA)', 'NOSE scale', 'Nasal Obstruction'], 'conditions': ['Nasal Obstruction', 'Septal Deformity', 'Turbinate Hypertrophy']}, 'referencesModule': {'references': [{'pmid': '15054369', 'type': 'BACKGROUND', 'citation': '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': '14574290', 'type': 'BACKGROUND', 'citation': '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': '8326220', 'type': 'BACKGROUND', 'citation': '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': '1448533', 'type': 'BACKGROUND', 'citation': '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': '4033334', 'type': 'BACKGROUND', 'citation': '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': '3718689', 'type': 'BACKGROUND', 'citation': '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': '11777241', 'type': 'BACKGROUND', 'citation': 'Moore EJ, Kern EB. Atrophic rhinitis: a review of 242 cases. Am J Rhinol. 2001 Nov-Dec;15(6):355-61.'}, {'pmid': '15054368', 'type': 'BACKGROUND', 'citation': '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': '14990910', 'type': 'BACKGROUND', 'citation': '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': '10334213', 'type': 'BACKGROUND', 'citation': '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': '9852527', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis study looks at two common procedures for turbinate reduction:\n\n1. 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.\n2. Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a piece off the turbinate, which also reduces its size.\n\nWhile both procedures improve nasal obstruction, no study has directly compared which is more effective.\n\nEighty patients being treated for septal deformity and turbinate hypertrophy will be randomly chosen for either PRIT or RFA treatment. They will fill out a simple, five question survey that measures how they view their nasal blockage 4 times in one year. We believe that since PRIT permanently removes a part of the turbinate, PRIT patients will report more improvement than RFA patients one year later. We believe that complications (measured by the doctor) will be the same for both treatments.", 'detailedDescription': "Subjective nasal obstruction is usually caused by intranasal anatomic obstruction. A critical area is the anterior nasal valve, and nasal septal deformity and inferior turbinate hypertrophy often combine to produce symptomatic obstruction at the anterior valve.\n\nSurgical treatments to reduce turbinate size and also to correct nasal septal deformity have been shown to be effective at improving nasal obstruction. While many studies have demonstrated the improvements after surgery, most prior studies assessed outcome using non-validated questionnaires, or primitive measures such as a single-item rating scale.\n\nThere is now a validated, patient-based, outcome instrument to assess nasal obstruction, which is valid, reliable, and sensitive: the Nasal Obstruction Symptom Evaluation (NOSE) scale (Stewart, Witsell, et al). This brief and easy to complete instrument is a valid measure of the patient's perception of nasal obstruction. A multi-center prospective study using the NOSE scale showed that septoplasty alone resulted in significant improvement in nasal obstruction, and septoplasty with PRIT had an even larger improvement in nasal obstruction, although the difference did not reach statistical significance because of sample size (Stewart, Smith, et al). Nevertheless, turbinate reduction appeared to have some additive effect on symptomatic improvement, which is a clinical findings that has been noted by surgeons for many years.\n\nThe techniques of inferior turbinectomy have evolved over time. Initially, partial or even total resection of the inferior turbinate was performed. However, total inferior turbinate resection was found to have a high rate of several long-term complications, including excessive dryness (rhinitis sicca), atrophic rhinitis, crusting, bleeding, etc. (Moore GF, Moore EJ), and this technique is generally not performed today. By extension, many surgeons have been concerned about the potential sequelae of partial inferior turbinectomy, even though large prospective series have demonstrated excellent outcomes and minimal complications from the PRIT technique (Fanous, Ophir, Grymer, Stewart/Smith).\n\nSeveral alternative techniques for turbinate volume reduction - that do not involve full-thickness resection of a portion of the turbinate - have been reported, and all seem to be effective in single-modality series (Nease, Bhattacharyya, Utley, Li). In fact, anecdotally many surgeons claim that RFA is as effective as PRIT. In addition, radiofrequency techniques can be performed under local anesthesia in the office setting, which increases the ease of use. While RFA is appealing because it can be performed under local anesthesia, the improved ease of use must be weighed against the potential for lower effectiveness, since tissue is not removed. There are no data from direct comparative studies, probably partly because there has not been a validated outcome tool available.\n\nTherefore, sufficient clinical equipoise exists to randomize patients to receive one of these two widely-accepted techniques."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study subjects will be male or female, 18 years or older, with nasal septal deformity and bilateral inferior turbinate hypertrophy\n\nExclusion Criteria:\n\n* Subjects with contraindication to general anesthesia or nasal surgery\n* Additional simultaneous nasal surgery, such as sinus surgery or rhinoplasty\n* Nasal polyposis and prior inferior turbinectomy'}, 'identificationModule': {'nctId': 'NCT00358267', 'briefTitle': 'Randomized Trial Comparing Partial Resection of Inferior Turbinate(PRIT) and Radiofrequency Ablation(RFA) for Inferior Turbinate Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Randomized Trial Comparing Two Surgical Techniques for Inferior Turbinate Reduction', 'orgStudyIdInfo': {'id': '0603008446'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RFA', 'description': "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.", 'interventionNames': ['Procedure: Radiofrequency Ablation (RFA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRIT', 'description': 'Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a small piece off the turbinate, which also reduces its size.', 'interventionNames': ['Procedure: Partial Resection of Inferior Turbinates (PRIT)']}], 'interventions': [{'name': 'Partial Resection of Inferior Turbinates (PRIT)', 'type': 'PROCEDURE', 'description': 'PRIT involves surgically removing a small piece off the turbinate, which also reduces its size.', 'armGroupLabels': ['PRIT']}, {'name': 'Radiofrequency Ablation (RFA)', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['RFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael G Stewart, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Michael G. Stewart MD MPH', 'oldOrganization': 'Weill Medical College of Cornell University'}}}}