Chronic Hypertrophic RhinosinusitisNCT02270125
Nanoparticles in Nasal Mucosa
An observational study of Chronic Hypertrophic Rhinosinusitis and Chronic Polypous Rhinosinusitis, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Chronic Hypertrophic Rhinosinusitis, Chronic Polypous Rhinosinusitis
- What is being tested?
- Mucotomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesCzechia
- Study dates
- Sep 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients with chronic hypertrophic rhinosinusitis, with or without polyposis Stillborn children
Who may be able to join
- 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
Who cannot join
- non-signing of the informed consent
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Nanotechnology Centre, VSB-Technical University Ostrava
Ostrava, Czech Republic, 708 33
University Hospital Ostrava
Ostrava, Czech Republic, 708 52
About this study
Official title: The Role of Nanoparticles in Inflammatory Changes of the 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.
Read the 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.
- Being tested
- Mucotomy
- Keywords
- nasal mucosa, chronic hypertrophic rhinosinusitis, mucotomy, nanoparticles, scanning electron microscopy, Raman microspectroscopy, nasal polyposis
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucotomyProcedure or surgery
Also called turbinoplasty
Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with chronic rhino sinusitis | Group of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis Receives: Procedure: Mucotomy | |
| Stillborn children | Control group of stillborn children whose nasal mucosa was not exposed to airborne particles Receives: Procedure: Mucotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (1)
The presence of nano particles in the nasal mucosa obtained from stillborn children
Confirmation of the presence of nano particle in the nasal mucosa obtained from stillborn children (Yes/No).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hypertrophic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- VSB - Technical University of Ostrava
- Responsible party
- Sponsor
- Investigators
- Lenka Čábalová, MD, Principal investigator, University Hospital Ostrava, Medical Faculty of the Ostrava University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270125
- Sponsor's protocol ID
- FNO-ENT-Nanoparticles
- Other IDs
- 2 RVO-FNOs/2013
- Status last verified
- Mar 2018
- First submitted
- 13 Oct 2014
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22678622Dvorackova 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.
PubMed 23235723Oberdorster 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.
PubMed 16002369
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa
- ClinicalTrials.gov ID
- NCT02270125
- Acronym / sponsor ID
- FNO-ENT-Nanoparticles
- Keywords
- nasal mucosa, chronic hypertrophic rhinosinusitis, mucotomy, nanoparticles, scanning electron microscopy, Raman microspectroscopy, nasal polyposis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- VSB - Technical University of Ostrava
- Study start
- Sep 2013
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult patients with chronic rhino sinusitis | – | Procedure: MucotomyGroup of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis |
| Stillborn children | – | Procedure: MucotomyControl group of stillborn children whose nasal mucosa was not exposed to airborne particles |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients with chronic hypertrophic rhinosinusitis, with or without polyposis Stillborn children
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- non-signing of the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MucotomyAlso: turbinoplastySurgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia | Procedure or surgery | Adult patients with chronic rhino sinusitis, Stillborn children |
Primary outcome
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.
1 secondary outcome
The presence of nano particles in the nasal mucosa obtained from stillborn children
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Background: PubMed 22678622Zelenik 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.
- Background: PubMed 23235723Dvorackova 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.
- Background: PubMed 16002369Oberdorster 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.
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Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenka Čábalová, MD principal investigator
University Hospital Ostrava, Medical Faculty of the Ostrava University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hypertrophic Rhinosinusitis and Chronic Polypous Rhinosinusitis, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection and characterisation of nano particles (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270125, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.