Ventriculoperitoneal ShuntNCT06664372
Insertion of Frontal Ventricular Catheter of VP Shunt in Congenital Hydrocephalus Guided by Trans Fontanelle Ultrasound
A study testing Trans fontanelle US Guided VP Shunt in people with Ventriculoperitoneal Shunt and Trans Fontanelle US, run by Assiut University.
Trial summary
The Aim of This Study Is To Evaluate The Role Of Ultrasound In Decreasing Rate Of Proximal Obstruction In Frontal VP Shunt Read more about this study
- Who is it for?
- Ages 5 days to 2 years
- Conditions the study is for
- Ventriculoperitoneal Shunt, Trans Fontanelle US, Congenital Hydrocephalus
- What is being tested?
- Trans fontanelle US Guided VP Shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 days to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who are diagnosed with congenital Hydrocephalus
- age of patients : < 2 years with patent Anterior Fontanelle
- Not operated with frontal shunt before
Who cannot join
- patients who are diagnosed with congenital Hydrocephalus
- age of patients : < 2 years with patent Anterior Fontanelle
- Not operated with frontal shunt before
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The Aim of This Study Is To Evaluate The Role Of Ultrasound In Decreasing Rate Of Proximal Obstruction In Frontal VP Shunt
Read the detailed description
Congenital Hydrocephalus is a very common congenital anomalie known as the abnormal accumulation of csf in the ventricles and subarachnoid spaces under high tension due to imbalance between synthesis and absorption of csf , The incidence of congenital hydrocephalus is higher in low income country than in high income countries Treatment options for hydrocephalus are multiple but the most common treatment option world wide is VP Shunt . Although, VP Shunt still has a high rate of failure as revisions are required in 30% - 40% of cases In Vp shunt insertion , the placement of ventricular catheter is done mainly by free hand technique but recently The trans fontanelle ultrasound guided placement of ventricular catheter become a standard technique in multiple centers The free hand technique has low accuracy rate in proper intraventricular placement of the proximal catheter than the ultrasound guided technique . On the other hand , the use of intra operative ultrasound can visualize the anatomy of lateral ventricles and choroid plexus which makes the placement of ventricular catheter more accurate than the blind free hand technique So we are aiming in this study to highlight the efficacy of ultrasound guided placement of ventricular catheter of the frontal shunt in decreasing the rate of proximal catheter obstruction and we choose the frontal shunt because it has an advantage over the occipital in rate of revisions as it has a lower rate
- Being tested
- Trans fontanelle US Guided VP Shunt
- Keywords
- ventriculoperitoneal shunt, Trans fontanelle US, Congenital hydrocephalus
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans fontanelle US Guided VP ShuntProcedure or surgery
Insertion of proximal VP shunt catheter by trans fontanelle US
| Study group | Role | What they receive |
|---|---|---|
| Trans fontanelle US Guided VP Shunt | Experimental | insertion of proximal vp shunt by trans fontanelle US Receives: Procedure: Trans fontanelle US Guided VP Shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate Of Proximal Revisions In Frontal Shunt
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Ventriculoperitoneal ShuntStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Salah Mohamed Omran, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664372
- Sponsor's protocol ID
- Transfontanelle US vp shunt
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Z, Zhang Y, Hu F, Ding J, Wang X. Pathogenesis and pathophysiology of idiopathic normal pressure hydrocephalus. CNS Neurosci Ther. 2020 Dec;26(12):1230-1240. doi: 10.1111/cns.13526. Epub 2020 Nov 26.
PubMed 33242372Sarikaya-Seiwert S, Schievelkamp AH, Born M, Wispel C, Haberl H, Shabo E. The impact of real-time ultrasound guidance on ventricular catheter placement in cerebrospinal fluid shunts - a single-center study. Ultraschall Med. 2025 Apr;46(2):170-176. doi: 10.1055/a-2352-9404. Epub 2024 Jun 25.
PubMed 38917967Kullmann M, Khachatryan M, Schuhmann MU. Ultrasound-guided placement of ventricular catheters in first-time pediatric VP shunt surgery. Childs Nerv Syst. 2018 Mar;34(3):465-471. doi: 10.1007/s00381-017-3660-2. Epub 2017 Nov 22.
PubMed 29167995
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion of Frontal Ventricular Catheter of VP Shunt in Congenital Hydrocephalus Guided by Trans Fontanelle Ultrasound
- ClinicalTrials.gov ID
- NCT06664372
- Acronym / sponsor ID
- Transfontanelle US vp shunt
- Keywords
- ventriculoperitoneal shunt, Trans fontanelle US, Congenital hydrocephalus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Oct 2024 (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.
The Aim of This Study Is To Evaluate The Role Of Ultrasound In Decreasing Rate Of Proximal Obstruction In Frontal VP Shunt
Detailed description
Congenital Hydrocephalus is a very common congenital anomalie known as the abnormal accumulation of csf in the ventricles and subarachnoid spaces under high tension due to imbalance between synthesis and absorption of csf , The incidence of congenital hydrocephalus is higher in low income country than in high income countries Treatment options for hydrocephalus are multiple but the most common treatment option world wide is VP Shunt . Although, VP Shunt still has a high rate of failure as revisions are required in 30% - 40% of cases In Vp shunt insertion , the placement of ventricular catheter is done mainly by free hand technique but recently The trans fontanelle ultrasound guided placement of ventricular catheter become a standard technique in multiple centers The free hand technique has low accuracy rate in proper intraventricular placement of the proximal catheter than the ultrasound guided technique . On the other hand , the use of intra operative ultrasound can visualize the anatomy of lateral ventricles and choroid plexus which makes the placement of ventricular catheter more accurate than the blind free hand technique So we are aiming in this study to highlight the efficacy of ultrasound guided placement of ventricular catheter of the frontal shunt in decreasing the rate of proximal catheter obstruction and we choose the frontal shunt because it has an advantage over the occipital in rate of revisions as it has a lower rate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trans fontanelle US Guided VP Shunt | Experimental | Procedure: Trans fontanelle US Guided VP Shuntinsertion of proximal vp shunt by trans fontanelle US |
Who may qualify
- Ages
- 5 days to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients who are diagnosed with congenital Hydrocephalus
- age of patients : < 2 years with patent Anterior Fontanelle
- Not operated with frontal shunt before
Key exclusion criteria (3 listed)
- patients who are diagnosed with congenital Hydrocephalus
- age of patients : < 2 years with patent Anterior Fontanelle
- Not operated with frontal shunt before
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 |
|---|---|---|
| Trans fontanelle US Guided VP ShuntInsertion of proximal VP shunt catheter by trans fontanelle US | Procedure or surgery | Trans fontanelle US Guided VP Shunt |
Primary outcome
Rate Of Proximal Revisions In Frontal Shunt
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 33242372Wang Z, Zhang Y, Hu F, Ding J, Wang X. Pathogenesis and pathophysiology of idiopathic normal pressure hydrocephalus. CNS Neurosci Ther. 2020 Dec;26(12):1230-1240. doi: 10.1111/cns.13526. Epub 2020 Nov 26.
- Background: PubMed 38917967Sarikaya-Seiwert S, Schievelkamp AH, Born M, Wispel C, Haberl H, Shabo E. The impact of real-time ultrasound guidance on ventricular catheter placement in cerebrospinal fluid shunts - a single-center study. Ultraschall Med. 2025 Apr;46(2):170-176. doi: 10.1055/a-2352-9404. Epub 2024 Jun 25.
- Background: PubMed 29167995Kullmann M, Khachatryan M, Schuhmann MU. Ultrasound-guided placement of ventricular catheters in first-time pediatric VP shunt surgery. Childs Nerv Syst. 2018 Mar;34(3):465-471. doi: 10.1007/s00381-017-3660-2. Epub 2017 Nov 22.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Trans fontanelle US Guided VP Shunt in people with Ventriculoperitoneal Shunt and Trans Fontanelle US, run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elsayed Mohamed Elsayed, Prof (+20 01016077797, mohamed.ahmed18@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate Of Proximal Revisions In Frontal Shunt (time frame: 2 years). 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 NCT06664372, 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 29 Oct 2024.