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Nanoparticles in Nasal Mucosa

U

University Hospital Ostrava

Status

Completed

Conditions

Chronic Polypous Rhinosinusitis
Chronic Hypertrophic Rhinosinusitis

Treatments

Procedure: Mucotomy

Study type

Observational

Funder types

Other

Identifiers

NCT02270125
FNO-ENT-Nanoparticles
2 RVO-FNOs/2013 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

19 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Adult patients with chronic rhino sinusitis
Description:
Group of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis
Treatment:
Procedure: Mucotomy
Stillborn children
Description:
Control group of stillborn children whose nasal mucosa was not exposed to airborne particles
Treatment:
Procedure: Mucotomy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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