Normal Pressure HydrocephalusNCT03245138
Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
A study testing Endoscopic Third Ventriculostomy and Ventriculo-Peritoneal Shunting in people with Normal Pressure Hydrocephalus, run by University Medicine Greifswald at 3 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Endoscopic Third Ventriculostomy and Ventriculo-Peritoneal Shunting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesGermany
- Study dates
- Jun 2016to Dec 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 50 years
- gait disturbances typical for iNPH
- symptoms Duration less than 36months
Who cannot join
- positive spinal TAP-test
- no informed consent
- malignant disease
- other diseases of the CNS (Parkinson, dementia)
- secondary communicating hydrocephalus
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Not yet recruiting
University Medicine Göttingen
Göttingen
Ingo Fiss, MD, ingo.fiss@med.uni-goettingen.de
Veit Rohde, MD, PhD, veit.rohde@med.uni-goettingen.de
- Recruiting
University Medicine Greifswald
Greifswald, 17489
Sascha Marx, MD, 00493834866163, marxs@uni-greifswald.de
Henry WS Schroeder, MD, PhD, 00493834866163, henry.schroeder@uni-greifswald.de
- Recruiting
Klinikum Neubrandenburg
Neubrandenburg
Aleksandra Smilgrin, MD, smilgina@dbknb.de
Michael Fritsch, MD, PhD, fritschm@dbknb.de
About this study
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.
Read the detailed description
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.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Endoscopic Third Ventriculostomy, Ventriculo-Peritoneal Shunting
- Keywords
- endoscopic third ventriculostomy, ventricular peritoneal shunt, communicating hydrocephalus
- Medical subject headings
- Hydrocephalus, Normal Pressure, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Third VentriculostomyProcedure or surgery
patients receive an endoscopic third ventriculotomy as surgical procedure
Ventriculo-Peritoneal ShuntingProcedure or surgery
patients receive an ventriculo-peritoneal shunt as surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| endoscopic third ventriculostomy | Experimental | endoscopic third ventriculostomy for the treatment of iNPH Receives: Procedure: Endoscopic Third Ventriculostomy |
| ventricular peritoneal shunt | Active comparator | Insertion of a ventriculo-peritoneal Shunt for the treatment of iNPH Receives: Procedure: Ventriculo-Peritoneal Shunting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kiefer Index
Improvment of at least 2 points
Measured: 1 year
Recovery Index
Improvment of at least 2 points
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Marx, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245138
- Sponsor's protocol ID
- ETV versus VPS in iNPH
- Status last verified
- Nov 2018
- First submitted
- 31 Jul 2017
- Last updated
- 6 Nov 2018
- 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 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT03245138
- Acronym / sponsor ID
- ETV versus VPS in iNPH
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- endoscopic third ventriculostomy, ventricular peritoneal shunt, communicating hydrocephalus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Aug 2017 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic third ventriculostomy | Experimental | Procedure: Endoscopic Third Ventriculostomyendoscopic third ventriculostomy for the treatment of iNPH |
| ventricular peritoneal shunt | Active comparator | Procedure: Ventriculo-Peritoneal ShuntingInsertion of a ventriculo-peritoneal Shunt for the treatment of iNPH |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 50 years
- gait disturbances typical for iNPH
- symptoms Duration less than 36months
Key exclusion criteria (5 listed)
- positive spinal TAP-test
- no informed consent
- malignant disease
- other diseases of the CNS (Parkinson, dementia)
- secondary communicating hydrocephalus
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 |
|---|---|---|
| Endoscopic Third Ventriculostomypatients receive an endoscopic third ventriculotomy as surgical procedure | Procedure or surgery | endoscopic third ventriculostomy |
| Ventriculo-Peritoneal Shuntingpatients receive an ventriculo-peritoneal shunt as surgical procedure | Procedure or surgery | ventricular peritoneal shunt |
Primary outcome
Kiefer Index
Time frame: 1 year
Improvment of at least 2 points
Recovery Index
Time frame: 1 year
Improvment of at least 2 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Third Ventriculostomy and Ventriculo-Peritoneal Shunting in people with Normal Pressure Hydrocephalus, run by University Medicine Greifswald at 3 sites in Germany.
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 3 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does the primary outcome measure?
Kiefer Index (time frame: 1 year). The study lists 2 primary outcomes in all. 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 6 Nov 2018.