Subjective and Objective Outcome of ESS in CRSwNP | NCT04868695

Studies
Subjective and Objective Outcome of ESS in CRSwNP

NCT04868695

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

May 8, 2024Actual

Enrollment

99Estimated

Phase

Not Applicable

Conditions

Interventions

1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Apr 27, 2021

First Submission Date that Met QC Criteria

Apr 27, 2021

First Posted Date

May 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3	Procedure	1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3	Bilateral Fronto-Spheno-Ethmoidectomy + Draf 2b

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nasal Polyp Score	Nasal Polyps	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Previous sinunasal surgery High resolution paranasal sinus CT shows other pathology (e.g. mucocele) Incapable of judgement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael B Soyka, MD	Contact	0432531460		rhinologie@usz.ch
Christian Meerwein, MD	Contact	0432531460		rhinologie@usz.ch

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zurich University Hospital	Recruiting	Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided