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Trial record 2 of 29 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"

Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus

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ClinicalTrials.gov Identifier: NCT03245138
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Sascha Marx, University Medicine Greifswald

July 31, 2017
August 10, 2017
August 10, 2017
June 2016
December 2018   (Final data collection date for primary outcome measure)
  • Kiefer Index [ Time Frame: 1 year ]
    Improvment of at least 2 points
  • Recovery Index [ Time Frame: 1 year ]
    Improvment of at least 2 points
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
An endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.
The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with obstructive hydrocephalus. However, in the last decade several reports highlighted an success of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled multicenter study.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Normal Pressure Hydrocephalus
  • Procedure: Endoscopic Third Ventriculostomy
    patients receive an endoscopic third ventriculotomy as surgical procedure
  • Procedure: Ventriculo-Peritoneal Shunting
    patients receive an ventriculo-peritoneal shunt as surgical procedure
  • Experimental: endoscopic third ventriculostomy
    endoscopic third ventriculostomy for the treatment of iNPH
    Intervention: Procedure: Endoscopic Third Ventriculostomy
  • Active Comparator: ventricular peritoneal shunt
    Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH
    Intervention: Procedure: Ventriculo-Peritoneal Shunting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
December 2020
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over 50 years
  • gait disturbances typical for iNPH
  • symptoms Duration less than 36months
  • exclusion of obstructive hydrocephalus
  • positive spinal TAP-test

Exclusion Criteria:

  • no informed consent
  • malignant disease
  • other diseases of the CNS (Parkinson, dementia)
  • secondary communicating hydrocephalus
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Germany
 
 
NCT03245138
ETV versus VPS in iNPH
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Sascha Marx, University Medicine Greifswald
University Medicine Greifswald
Not Provided
Not Provided
University Medicine Greifswald
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP