RhinosinusitisNCT01296919
The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis
An observational study of Rhinosinusitis, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic rhinosinusitis whose uncinate process had to be removed to enable surgical access to the sinuses.
Who may be able to join
- Patients with chronic rhinosinusitis who:
- Failed conservative medical treatment.
- Stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.
- Had a Lund-MacKay CT score of 2 and higher of 24 available.
Who cannot join
- Immunosuppressed patients.
- Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
- Patients with a Lund-MacKay CT score < 2 of 24 available.
- Pregnant women.
- Patients who underwent prior endoscopic sinus surgery.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
AssutaHS
Tel Aviv
Eitan Yaniv, MD, 052-2509890, docyaniv@yahoo.com
Roee Landsberg, MD, 052-4266359
About this study
Official title: New Insights on the Clinical Significance of the Uncinate Process Histopathology in Patients With Chronic Rhinosinusitis
Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.
Read the detailed description
The purpose of the present study is to gain insight into the histopathological changes of the uncinate process in patients with chronic rhinosinusitis through comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).
- Conditions
- Rhinosinusitis
- Keywords
- Chronic rhinosinusitis, Histopathology, Infundibulum, Lamina propria, Uncinate process
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sinus drainage | Adult patients with chronic rhinosinusitis who failed treatment with antibiotics and topical corticosteroids and underwent endoscopic sinus surgery. Preoperative evaluation included paranasal sinus CT scans. The diagnosis was confirmed by endoscopic examination showing purulent and/or mucopurulent discharge in the middle and/or superior meatus. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilead Berger, MD, Principal investigator, AssutaHS, Meir Medical CenterEitan Yaniv, MD, Study chair, Assuta Hospital SystemsRoee Landsberg, MD, Study director, Assuta Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296919
- Sponsor's protocol ID
- AssutaHS10-2010037
- Status last verified
- Feb 2011
- First submitted
- 14 Feb 2011
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Insights on the Clinical Significance of the Uncinate Process Histopathology in Patients With Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT01296919
- Acronym / sponsor ID
- AssutaHS10-2010037
- Conditions
- Rhinosinusitis
- Keywords
- Chronic rhinosinusitis, Histopathology, Infundibulum, Lamina propria, Uncinate process
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Feb 2011 (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.
Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.
Detailed description
The purpose of the present study is to gain insight into the histopathological changes of the uncinate process in patients with chronic rhinosinusitis through comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinus drainage | – | –Adult patients with chronic rhinosinusitis who failed treatment with antibiotics and topical corticosteroids and underwent endoscopic sinus surgery. Preoperative evaluation included paranasal sinus CT scans. The diagnosis was confirmed by endoscopic examination showing purulent and/or mucopurulent discharge in the middle and/or superior meatus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic rhinosinusitis whose uncinate process had to be removed to enable surgical access to the sinuses.
Key inclusion criteria (4 listed)
- Failed conservative medical treatment.
- Stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.
- Had a Lund-MacKay CT score of 2 and higher of 24 available.
Key exclusion criteria (5 listed)
- Immunosuppressed patients.
- Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
- Patients with a Lund-MacKay CT score < 2 of 24 available.
- Pregnant women.
- Patients who underwent prior endoscopic sinus surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
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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.
Gilead Berger, MD principal investigator
AssutaHS, Meir Medical Center
Eitan Yaniv, MD study chair
Assuta Hospital Systems
Roee Landsberg, MD study director
Assuta Hospital Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinosinusitis, run by Assuta Hospital Systems at 1 site in Israel.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 13 Sep 2011.