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Completed

NCT Number: NCT02270125

Nanoparticles in Nasal Mucosa

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.

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanotechnology Centre, VSB-Technical University Ostrava, Ostrava, Czech Republic, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mucotomy

Procedure

Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia

Other names: turbinoplasty

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • VSB - Technical University of Ostrava

Registry information

Official study title

The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 21, 2014
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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