NCT02270125

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

4.2 years

First QC Date

October 13, 2014

Last Update Submit

March 29, 2018

Conditions

Chronic Hypertrophic RhinosinusitisChronic Polypous Rhinosinusitis

Keywords

nasal mucosachronic hypertrophic rhinosinusitismucotomynanoparticlesscanning electron microscopyRaman microspectroscopynasal polyposis

Outcome Measures

Primary Outcomes (1)

  • Detection and characterisation of nano particles

    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.

    36 months

Secondary Outcomes (1)

  • The presence of nano particles in the nasal mucosa obtained from stillborn children

    36 months

Study Arms (2)

Adult patients with chronic rhino sinusitis

Group of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis

Procedure: Mucotomy

Stillborn children

Control group of stillborn children whose nasal mucosa was not exposed to airborne particles

Procedure: Mucotomy

Interventions

MucotomyPROCEDURE

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

Also known as: turbinoplasty
Adult patients with chronic rhino sinusitisStillborn children

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Adult patients with chronic hypertrophic rhinosinusitis, with or without polyposis Stillborn children

You may qualify if:

  • 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

You may not qualify if:

  • \- non-signing of the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanotechnology Centre, VSB-Technical University Ostrava

Ostrava, Czech Republic, 708 33, Czechia

Location

University Hospital Ostrava

Ostrava, Czech Republic, 708 52, Czechia

Location

Related Publications (3)

  • Zelenik K, Kukutschova J, Dvorackova J, Bielnikova H, Peikertova P, Cabalova L, Kominek P. Possible role of nano-sized particles in chronic tonsillitis and tonsillar carcinoma: a pilot study. Eur Arch Otorhinolaryngol. 2013 Feb;270(2):705-9. doi: 10.1007/s00405-012-2069-5. Epub 2012 Jun 8.

    PMID: 22678622BACKGROUND

  • Dvorackova J, Bielnikova H, Kukutschova J, Peikertova P, Filip P, Zelenik K, Kominek P, Uvirova M, Pradna J, Cermakova Z, Dvoracek I. Detection of nano- and micro-sized particles in routine biopsy material - pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Mar;159(1):87-92. doi: 10.5507/bp.2012.104. Epub 2012 Dec 10.

    PMID: 23235723BACKGROUND

  • Oberdorster G, Oberdorster E, Oberdorster J. Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect. 2005 Jul;113(7):823-39. doi: 10.1289/ehp.7339.

    PMID: 16002369BACKGROUND

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

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lenka Čábalová, MD

    University Hospital Ostrava, Medical Faculty of the Ostrava University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 21, 2014

Study Start

September 1, 2013

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

CZ(2)