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Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success - Trial NCT04773938

Access comprehensive clinical trial information for NCT04773938 through Pure Global AI's free database. This phase not specified trial is sponsored by Rigshospitalet, Denmark and is currently Recruiting. The study focuses on Hydrocephalus. Target enrollment is 1000 participants.

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NCT04773938
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Trial Details
ClinicalTrials.gov โ€ข NCT04773938
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Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success
Endoscopic Third Ventriculostomy for Adults With Hydrocephalus: Creating a Prognostic Model for Success - A Retrospective Multicenter Study

Study Focus

Hydrocephalus

Observational

Sponsor & Location

Rigshospitalet, Denmark

Aalborg,Aarhus,Copenhagen,Odense,Helsinki,Kuopio,Oulu,Turku,Bergen,Oslo,Oslo,Tromsรธ,Trondheim,Gรถteborg,Linkรถping,Lund,Stockholm,Umeรฅ,Uppsala, Denmark,Finland,Norway,Sweden

Timeline & Enrollment

N/A

May 27, 2020

Dec 01, 2021

1000 participants

Primary Outcome

ETV success

Summary

Endoscopic Third Ventriculostomy for Adults with Hydrocephalus: Creating a Prognostic Model
 for Success - A Retrospective Multicenter Study
 
 Background: Endoscopic third ventriculostomy (ETV) is becoming an increasingly widespread
 treatment for hydrocephalus, but most of the research is based on paediatric populations. The
 ETV Success Score (ETVSS) was developed in 2009 to predict the outcome of ETV in children.
 There is no similar tool for predicting outcome in adults.
 
 Objective: The purpose of this study is to create a prognostic model to predict the success
 of ETV for adult patients with hydrocephalus
 
 Methods: The study will adhere to the TRIPOD reporting guidelines and will be conducted as a
 retrospective chart review of all patients โ‰ฅ18 years old treated with ETV at the
 participating centres between Jan 1st, 2010 and Dec 31st, 2018. Data collection is conducted
 locally in REDCap. Univariate analyses will be used to identify several strong predictors to
 be included in a multivariate logistic regression model. The model will be validated using
 K-fold cross validation. Discrimination will be assesses using AUROC and calibration with
 calibration belt plots.
 
 Expected outcomes: The ability to predict who will benefit from an ETV will allow better
 primary patient selection both for ETV and shunting. This would reduce additional second
 procedures due to primary treatment failure. A success score specific for adults could also
 be used as a communication tool to provide better information and guidance to patients.

ICD-10 Classifications

Hydrocephalus
Hydrocephalus, unspecified
Other hydrocephalus
Congenital hydrocephalus
Obstructive hydrocephalus

Data Source

ClinicalTrials.gov

NCT04773938

Non-Device Trial