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Nanoparticles in Nasal Mucosa

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by University Hospital Ostrava
Sponsor:
Collaborator:
VSB - Technical University of Ostrava
Information provided by (Responsible Party):
University Hospital Ostrava
ClinicalTrials.gov Identifier:
NCT02270125
First received: October 13, 2014
Last updated: February 13, 2017
Last verified: February 2017
  Purpose
The aim of this prospective study is to evaluate presence and quantity of nano-sized particles and interindividual differences in their distribution and elemental composition in human nasal mucosa obtained by mucotomy in patients diagnosed with chronic hypertrophic rhinosinusitis and to compare the obtained results with control specimen obtained from stillborn children.

Condition Intervention
Chronic Hypertrophic Rhinosinusitis Chronic Polypous Rhinosinusitis Procedure: Mucotomy

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa

Resource links provided by NLM:


Further study details as provided by University Hospital Ostrava:

Primary Outcome Measures:
  • Detection and characterisation of nano particles [ Time Frame: 36 months ]
    Morphology characterization and elemental composition of the particles found in the nasal mucosa assessed with SEM (Quanta FEG 450, FEI) with X-ray microanalysis APOLLO X (EDAX) and SEM Philips XL 30 operating at 30 keV.


Secondary Outcome Measures:
  • The presence of nano particles in the nasal mucosa obtained from stillborn children [ Time Frame: 36 months ]
    Confirmation of the presence of nano particle in the nasal mucosa obtained from stillborn children (Yes/No).


Biospecimen Retention:   Samples Without DNA
nasal mucosa of the inferior nasal turbinate obtained by mucotomy in adult pacients nasal mucosa of the inferior nasal turbinate obtained by mucotomy in stillborn children

Estimated Enrollment: 35
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adult patients with chronic rhino sinusitis
Group of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis
Procedure: Mucotomy
Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia
Other Name: turbinoplasty
Stillborn children
Control group of stillborn children whose nasal mucosa was not exposed to airborne particles
Procedure: Mucotomy
Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia
Other Name: turbinoplasty

Detailed Description:

Samples of nasal mucosa are obtained by mucotomy in general anesthaesia from adult patients with chronic hypertrophic rhinosinusitis. Each tissue sample is divided into 4 parts based on the distance from the nostrils and is dehydrated, thinly sliced and mounted on glass slides. Then the tissue is analyzed with scanning electron microscopy (SEM) and Raman microspectroscopy (RMS) to detect solid particles and characterize the morphology and compositions of the detected particles. A novel method of quantification of distribution of the particles has been designed and used to evaluate interindividual differences in distribution of the particles. History of employment is obtained from the patients and the data are compared with the findings in the tissue samples.

The data acquired from the group of adult patients are compared with the results obtained from a group of control specimen of nasal mucosa harvested from stillborn children. It is presumed that no nano particles will be present in the stillborn children specimen since the mucosa was not exposed to airborne particles.

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with chronic hypertrophic rhinosinusitis, with or without polyposis Stillborn children
Criteria

Inclusion Criteria:

  • chronic hypertrophic rhihosinusitis without polyposis non responsive to conservative treatment for at least six months
  • chronic hypertrophic rhihosinusitis with polyposis non responsive to conservative treatment for at least six months
  • age between 19 and 64 years of age
  • signed informed consent of the patient
  • stillborn children born after 28th week of gestation

Exclusion Criteria:

- non-signing of the informed consent

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02270125

Contacts
Contact: Václav Procházka, MD,PhD,MSc +42059737 ext 2510 vaclav.prochazka@fno.cz
Contact: Jiří Hynčica +420597372587 jiri.hyncica@fno.cz

Locations
Czech Republic
Nanotechnology Centre, VSB-Technical University Ostrava Recruiting
Ostrava, Czech Republic, 708 33
Contact: Kristina Čabanová, Mgr.    +420597321557    kristina.cabanova@vsb.cz   
Contact: Jana Kukutschová, doc., Ing., PhD    +420597321557    jana.kukutschova@vsb.cz   
Principal Investigator: Kristina Čabanová, Mgr.         
Sub-Investigator: Jana Kukutschová, doc.Ing.PhD         
University Hospital Ostrava Recruiting
Ostrava, Czech Republic, 708 52
Contact: Jiri Hyncica, Bc.    +420597372510    jiri.hyncica@fno.cz   
Contact: Vaclav Prochazka, MD,PhD,MSc    +420597372544    angio@vol.cz   
Principal Investigator: Lenka Čábalová, MD         
Sub-Investigator: Karol Zeleník, MD, PhD         
Sub-Investigator: Pavel Komínek, prof.,MD,PhD,MBA         
Sub-Investigator: Jana Dvořáčková, doc.,MD,PhD         
Sub-Investigator: Hana Bielniková, Mgr.         
Sponsors and Collaborators
University Hospital Ostrava
VSB - Technical University of Ostrava
Investigators
Principal Investigator: Lenka Čábalová, MD University Hospital Ostrava, Medical Faculty of the Ostrava University
  More Information

Publications:
Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02270125     History of Changes
Other Study ID Numbers: FNO-ENT-Nanoparticles
2 RVO-FNOs/2013 ( Other Grant/Funding Number: Ministry of Health of the Czech Republic )
Study First Received: October 13, 2014
Last Updated: February 13, 2017

Keywords provided by University Hospital Ostrava:
nasal mucosa
chronic hypertrophic rhinosinusitis
mucotomy
nanoparticles
scanning electron microscopy
Raman microspectroscopy
nasal polyposis

Additional relevant MeSH terms:
Hypertrophy
Sinusitis
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017