HydrocephalusGAVCANCT01811589
Guided Application of Ventricular Catheters
A study testing Thomale-Guide and Free-hand in people with Hydrocephalus, run by Aesculap AG at 9 sites in Germany.
Trial summary
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can achieve a more precise placement of ventricular catheters than the standard free-hand… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Thomale-Guide and Free-hand
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 9 sitesGermany
- Study dates
- May 2013to Jan 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients requiring a permanent ventricular catheter for the treatment of CSF (cerebrospinal fluid) - circulation disorder or another disease (ventricular shunt oder Ommaya/Rickham-Reservoir)
- Frontal occipital horn ratio (FOHR) < 0.5
- Use of a new puncture channel
- Frontal access to the ventricles
- Patient´s informed consent
Who cannot join
- Known unevenness of the skull at the entry point
- Slit ventricles; Frontal and occipital horn width ratio (FOHWR) < 0.05
- Participation in another clinical trial with interfering endpoints
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Charité University Hospital, Division of Pediatric Neurosurgery
Berlin, 13353
Trauma Hospital Berlin, Clinic for Neurosurgery
Berlin
University Hospital Düsseldorf, Clinic for Neurosurgery
Düsseldorf
Univeristätsmedizin Göttingen, Neurochirurgie
Göttingen, 37075
Medizinische Hochschule Hannover, Neurochirurgie
Hanover, 30625
Heidelberg University Hospital, Department of Neurosurgery
Heidelberg
Klinikum Kassel GmbH / Department of Neurosurgery
Kassel
Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery
Neubrandenburg
University Hospital Tübingen, Department of Neurosurgery
Tübingen
About this study
Official title: Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can achieve a more precise placement of ventricular catheters than the standard free-hand placement technique.
Read the detailed description
Free-hand placement of ventricular catheters (VC) is reported to be inaccurate in 10-40%. Furthermore, there is evidence that the quality of VC positioning is correlating with the risk for proximal shunt obstruction. Ultrasound or neuronavigation are used in order to improve to placement. However, they are associated with significant technical efforts and increased time.
In this study a simple instrument assisted by a smart phone application software is used in order to achieve precise placement of ventricular catheters. The results are compared with the standard free-hand procedure. Patients requiring a ventricular catheter are randomized to one of the two treatments. The primary outcome parameter is a qualitative and quantitative assessment of the position of the ventricular catheter on a post-operative image. The evaluation of the primary criteria is performed by a radiologist blinded to the randomization arm.
- Conditions
- Hydrocephalus
- Being tested
- Thomale-Guide, Free-hand
- Keywords
- ventricular catheter, hydrocephalus, shunt, brain disease
- Medical subject headings
- Hydrocephalus, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thomale-GuideDevice
Ventricular catheter placement with the Thomale-Guide instrument
Free-handOther
Ventricular catheter placement without a guidance (free-hand)
| Study group | Role | What they receive |
|---|---|---|
| Thomale-Guide | Experimental | Positioning of ventricular catheter with the Thomale-Guide instrument Receives: Device: Thomale-Guide |
| Free-hand | Other | Ventricular catheter placement without a guidance (free-hand) Receives: Other: Free-hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle
Measured: Within the first 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich W Thomale, PD Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811589
- Sponsor's protocol ID
- AAG-G-H1221
- Acronym
- GAVCA
- Status last verified
- Jun 2019
- First submitted
- 13 Mar 2013
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomale UW, Knitter T, Schaumann A, Ahmadi SA, Ziegler P, Schulz M, Miethke C. Smartphone-assisted guide for the placement of ventricular catheters. Childs Nerv Syst. 2013 Jan;29(1):131-9. doi: 10.1007/s00381-012-1943-1. Epub 2012 Oct 23.
PubMed 23089936Thomale UW, Schaumann A, Stockhammer F, Giese H, Schuster D, Kastner S, Ahmadi AS, Polemikos M, Bock HC, Golz L, Lemcke J, Hermann E, Schuhmann MU, Beez T, Fritsch M, Orakcioglu B, Vajkoczy P, Rohde V, Bohner G. GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique. Neurosurgery. 2018 Aug 1;83(2):252-262. doi: 10.1093/neuros/nyx420.
PubMed 28973670Schaumann A, Thomale UW. Guided Application of Ventricular Catheters (GAVCA)--multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail. Trials. 2013 Dec 12;14:428. doi: 10.1186/1745-6215-14-428.
PubMed 24330776
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.
- ClinicalTrials.gov ID
- NCT01811589
- Acronym / sponsor ID
- GAVCA / AAG-G-H1221
- Conditions
- Hydrocephalus
- Keywords
- ventricular catheter, hydrocephalus, shunt, brain disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Mar 2013 (estimated)
- 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.
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can achieve a more precise placement of ventricular catheters than the standard free-hand placement technique.
Detailed description
Free-hand placement of ventricular catheters (VC) is reported to be inaccurate in 10-40%. Furthermore, there is evidence that the quality of VC positioning is correlating with the risk for proximal shunt obstruction. Ultrasound or neuronavigation are used in order to improve to placement. However, they are associated with significant technical efforts and increased time.
In this study a simple instrument assisted by a smart phone application software is used in order to achieve precise placement of ventricular catheters. The results are compared with the standard free-hand procedure. Patients requiring a ventricular catheter are randomized to one of the two treatments. The primary outcome parameter is a qualitative and quantitative assessment of the position of the ventricular catheter on a post-operative image. The evaluation of the primary criteria is performed by a radiologist blinded to the randomization arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thomale-Guide | Experimental | Device: Thomale-GuidePositioning of ventricular catheter with the Thomale-Guide instrument |
| Free-hand | Other | Other: Free-handVentricular catheter placement without a guidance (free-hand) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients requiring a permanent ventricular catheter for the treatment of CSF (cerebrospinal fluid) - circulation disorder or another disease (ventricular shunt oder Ommaya/Rickham-Reservoir)
- Frontal occipital horn ratio (FOHR) < 0.5
- Use of a new puncture channel
- Frontal access to the ventricles
- Patient´s informed consent
Key exclusion criteria (3 listed)
- Known unevenness of the skull at the entry point
- Slit ventricles; Frontal and occipital horn width ratio (FOHWR) < 0.05
- Participation in another clinical trial with interfering endpoints
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 |
|---|---|---|
| Thomale-GuideVentricular catheter placement with the Thomale-Guide instrument | Device | Thomale-Guide |
| Free-handVentricular catheter placement without a guidance (free-hand) | Other | Free-hand |
Primary outcome
Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle
Time frame: Within the first 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Background: PubMed 23089936Thomale UW, Knitter T, Schaumann A, Ahmadi SA, Ziegler P, Schulz M, Miethke C. Smartphone-assisted guide for the placement of ventricular catheters. Childs Nerv Syst. 2013 Jan;29(1):131-9. doi: 10.1007/s00381-012-1943-1. Epub 2012 Oct 23.
- Results publication: PubMed 28973670Thomale UW, Schaumann A, Stockhammer F, Giese H, Schuster D, Kastner S, Ahmadi AS, Polemikos M, Bock HC, Golz L, Lemcke J, Hermann E, Schuhmann MU, Beez T, Fritsch M, Orakcioglu B, Vajkoczy P, Rohde V, Bohner G. GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique. Neurosurgery. 2018 Aug 1;83(2):252-262. doi: 10.1093/neuros/nyx420.
- Derived from this study: PubMed 24330776Schaumann A, Thomale UW. Guided Application of Ventricular Catheters (GAVCA)--multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail. Trials. 2013 Dec 12;14:428. doi: 10.1186/1745-6215-14-428.
Related trials for Hydrocephalus
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Active, not recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
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.
Ulrich W Thomale, PD Dr. med. principal investigator
Charite University, Berlin, Germany
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thomale-Guide and Free-hand in people with Hydrocephalus, run by Aesculap AG at 9 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle (time frame: Within the first 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01811589, which also lists 3 linked publications.
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 Jun 2019.