A clinical study is an experimental evaluation of a product, substance, drug, diagnostic or therapeutic technique that, in its application to humans, aims to assess its efficacy and safety.
Since 2020 Flowgy has been conducting clinical studies in the Spanish hospitals Virgen del Rocio in Seville, Arrixaca and Morales Meseguer in Murcia and the Hospital General Universitario in Valencia, approved by the ethics committees of each of the hospitals mentioned above to determine the benefit of surgery in patients with nasal obstruction after the previous study with computational fluid dynamics (CFD).
Clinical Background.
Nasal obstruction is a very frequent reason for consultation in Otolaryngology [I], being the cardinal symptom of many common conditions of the nose [II].
The current diagnostic methodology based, among other methods, on anamnesis, physical examination, active anterior rhinomanometry or acoustic rhinomanometry does not establish, in a large percentage of cases, a direct correlation between the symptoms manifested by the patient and the findings of the physical examination and complementary examinations [V], [VI], [VII], [VIII], [IX], [X], [XI], [XII], [XIII]. This deficit in the current diagnostic methodology leads to misdiagnosis, treatment failure and sometimes iatrogenesis [XIV]. In the last ten years, a percentage of persistence of nasal obstruction after surgery of 9 to 41% of cases has been documented [XV], [XVI], [XVII], [XVIII].
Objectives of the clinical trial.
To address both the lack of correlation between the nasal obstruction manifested by some patients and the clinical findings, and the persistence of this symptom after treatment, it is obvious that in the management of patients with nasal obstruction it is necessary to create new diagnostic and therapeutic strategies, to identify and quantify the problem more accurately and, at the same time, to favor a better therapeutic performance.In this context, computational fluid dynamics (CFD) becomes a very promising option for the scientific support of the diagnosis and surgical planning of nasal pathologies, thanks to its ability to analyze and solve airflow problems in the nasal cavity.
Although CFD has been used for the study of airflow in the nasal cavities for more than 25 years, with the exception of Flowgy there are no applications that have demonstrated its clinical efficacy in the field of Rhinology [XIX], [XX].The clinical studies of Flowgy aim to determine the success rate of nasal obstruction surgery using CFD and virtual surgery techniques, as well as to evaluate to what extent the use of Flowgy can modify the surgical indication in patients with nasal obstruction.
Clinical study status.
Although the duration of the study was scheduled for one year, the outbreak of the worldwide health pandemic and the annexation of other hospitals to the clinical study have caused the publication of results to be postponed.
For the moment we can say that the results are far exceeding the most optimistic hypotheses. From here we will be presenting the results as we close them. Stay tuned!
Citations
[I] Bhattacharyya N. Clinical presentation, diagnosis, and treatment of nasal obstruction- UpToDate. Literature review current through: Jun 2018 | This topic last updated: May 07, 2018.
[II] Wang MB. Etiologies of nasal symptoms: An overview. UpToDate. Literature review current through: Jun 2018 | This topic last updated: Jun 21, 2018.
[III] Larrosa F et al. Adaptation and validation of the Spanish version of the Nasal Obstruction Symptom Evaluation (NOSE) Scale. Rhinology. 2015 Jun;53(2):176-80.
[IV] Hendry J et al. The Glasgow Benefit Inventory: a systematic review of the use and value of an otorhinolaryngological generic patient-recorded outcome measure. Clin Otolaryngol. 2016 Jun;41(3):259-75.
[V] Fraser L, Kelly G. An evidence-based approach to the management of the adult with nasal obstruction. Clin Otolaryngol. 2009 Apr;34(2):151-5.
[VI] Aziz T et al. Measurement tools for the diagnosis of nasal septal deviation: a systematic review. J Otolaryngol Head Neck Surg. 2014 Apr 24;43:11.
[VII] Rhee JS et al. A systematic review of patient-reported nasal obstruction scores: defining normative and symptomatic ranges in surgical patients. JAMA Facial Plast Surg. 2014 May-Jun;16(3):219-25.
[VIII] Stewart MG, Smith TL. Objective versus subjective outcomes assessment in rhinology. Am J Rhinol. 2005 Sep-Oct;19(5):529-35.
[IX] Huang ZL et al. Evaluation of nasal cavity by acoustic rhinometry in Chinese, Malay and Indian ethnic groups. Acta Otolaryngol. 2001Oct;121(7):844-8.
[X] Bermüller C et al. Diagnostic Accuracy of Peak Nasal Inspiratory Flow and Rhinomanometry in Functional Rhinosurgery. Laryngoscope, 118:605– 610, 2008.
[XI] André RF et al. Correlation between subjective and objective evaluation of the nasal airway. A systematic review of the highest level of evidence. Clin Otolaryngol. 2009 Dec;34(6):518-25.
[XII] van Spronsen E et al. Evidence-based recommendations regarding the differential diagnosis and assessment of nasal congestion: using the new GRADE system. Allergy 2008 Jul;63(7):820-33.
[XIII] Mohan S et al. Diagnostic and Therapeutic Management of Nasal Airway Obstruction: Advances in Diagnosis and Treatment. JAMA Facial Plast Surg. 2018 May 10.
[XIV] Bateman ND, Woolford TJ. Informed consent for septal surgery: the evidence-base. J Laryngol Otol. 2003 Mar;117(3):186-9.
[XV] Larson DA, Cilento BW. Systematic functional assessment of nasal dyspnea: surgical outcomes and predictive ability. Otolaryngol Head Neck Surg. 2011 Nov;145(5):845-50.
[XVI] Becker SS et al. Revision septoplasty: review of sources of persistent nasal obstruction. Am J Rhinol. 2008 Jul-Aug;22(4):440-4.
[XVII] Trimarchi M et al. Back-and-forth endoscopic septoplasty: analysis of the technique and outcomes. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):40-4.
[XVIII] Guyuron B. Is packing after septorhinoplasty necessary? A randomized study. Plast Reconstr Surg. 989 Jul;84(1):41-4; discussion 45-6.
[XIX] Quadrio M et al. Review of computational fluid dynamics in the assessment of nasal air flow and analysis of its limitations. Eur Arch Otorhinolaryngol.2014 Sep;271(9):2349-54.
[XX] Vogt K et al. The new agreement of the international RIGA consensus conference on nasal airway function tests. Rhinology. 2018 Jan 21.
