CRSNCT04868695
Subjective and Objective Outcome of ESS in CRSwNP
A study testing 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 in people with CRS, run by University of Zurich at 1 site in Switzerland.
Trial summary
(A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- CRS
- What is being tested?
- 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2021to 1 Mar 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic CRSwNP patients without improvement after conservative treatment for at least 6 months Extent of disease at least Davos Polyp Score ≥ 4 points Age 18-65 years Signed consent
Who cannot join
- Previous sinunasal surgery High resolution paranasal sinus CT shows other pathology (e.g. mucocele) Incapable of judgement
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Zurich University Hospital
Zurich, 8091
Michael Soyka, Dr.med., +41 44 255 11 11, michael.soyka@usz.ch
Michael Soyka, Dr.med.
About this study
Official title: Subjective and Objective Outcom Eof Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis With Nasal Polyps
(A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der mittleren Nasenmuschel.
(B): Beidseitige Fronto-Spheno-Ethmoidektomie mit maximaler Erweiterung des Zuganges zur Stirnhöhle (Draf Typ III): Unter einem Draf Typ III verste. (C) Beidseitige Spheno-Ethmoidektomie: Abtragung des Processus uncinatus, die Eröffnung der Kieferhöhle, die Eröffnung des vorderen und hinteren Siebbeinsystems und die Eröffnung der Keilbeinhöhle.
Read the detailed description
(A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der mittleren Nasenmuschel.
(B): Beidseitige Fronto-Spheno-Ethmoidektomie mit maximaler Erweiterung des Zuganges zur Stirnhöhle (Draf Typ III): Unter einem Draf Typ III verste. (C) Beidseitige Spheno-Ethmoidektomie: Abtragung des Processus uncinatus, die Eröffnung der Kieferhöhle, die Eröffnung des vorderen und hinteren Siebbeinsystems und die Eröffnung der Keilbeinhöhle.
- Conditions
- CRS
- Being tested
- 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3Procedure or surgery
- Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Spheno-Ethmoidectomy: | Experimental | Not described Receives: Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 |
| Bilateral Fronto-Spheno-Ethmoidectomy + Draf 2b | Experimental | Not described Receives: Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 |
| Draf Typ 3 | Experimental | Not described Receives: Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Polyp Score
Nasal Polyps
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Apr 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRSStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868695
- Sponsor's protocol ID
- ID 2020-00322
- Status last verified
- May 2024
- First submitted
- 27 Apr 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Objective Outcom Eof Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT04868695
- Acronym / sponsor ID
- ID 2020-00322
- Conditions
- CRS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 3 May 2021 (actual)
- 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.
(A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der mittleren Nasenmuschel.
(B): Beidseitige Fronto-Spheno-Ethmoidektomie mit maximaler Erweiterung des Zuganges zur Stirnhöhle (Draf Typ III): Unter einem Draf Typ III verste. (C) Beidseitige Spheno-Ethmoidektomie: Abtragung des Processus uncinatus, die Eröffnung der Kieferhöhle, die Eröffnung des vorderen und hinteren Siebbeinsystems und die Eröffnung der Keilbeinhöhle.
Detailed description
(A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der mittleren Nasenmuschel.
(B): Beidseitige Fronto-Spheno-Ethmoidektomie mit maximaler Erweiterung des Zuganges zur Stirnhöhle (Draf Typ III): Unter einem Draf Typ III verste. (C) Beidseitige Spheno-Ethmoidektomie: Abtragung des Processus uncinatus, die Eröffnung der Kieferhöhle, die Eröffnung des vorderen und hinteren Siebbeinsystems und die Eröffnung der Keilbeinhöhle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Spheno-Ethmoidectomy: | Experimental | Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 |
| Bilateral Fronto-Spheno-Ethmoidectomy + Draf 2b | Experimental | Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 |
| Draf Typ 3 | Experimental | Procedure: 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic CRSwNP patients without improvement after conservative treatment for at least 6 months Extent of disease at least Davos Polyp Score ≥ 4 points Age 18-65 years Signed consent
Key exclusion criteria (1 listed)
- Previous sinunasal surgery High resolution paranasal sinus CT shows other pathology (e.g. mucocele) Incapable of judgement
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 |
|---|---|---|
| 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 31) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 | Procedure or surgery | Bilateral Fronto-Spheno-Ethmoidectomy + Draf 2b, Bilateral Spheno-Ethmoidectomy:, Draf Typ 3 |
Primary outcome
Nasal Polyp Score
Time frame: 12 months
Nasal Polyps
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3 in people with CRS, run by University of Zurich at 1 site in Switzerland.
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 1 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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 Switzerland. 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?
Contact Michael B Soyka, MD (0432531460, rhinologie@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Polyp Score (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 8 May 2024.