NCT06664372

Brief Summary

The Aim of This Study Is To Evaluate The Role Of Ultrasound In Decreasing Rate Of Proximal Obstruction In Frontal VP Shunt

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Dec 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 28, 2024

Last Update Submit

October 28, 2024

Conditions

Keywords

ventriculoperitoneal shuntTrans fontanelle USCongenital hydrocephalus

Outcome Measures

Primary Outcomes (1)

  • Rate Of Proximal Revisions In Frontal Shunt

    2 years

Study Arms (1)

Trans fontanelle US Guided VP Shunt

EXPERIMENTAL

insertion of proximal vp shunt by trans fontanelle US

Procedure: Trans fontanelle US Guided VP Shunt

Interventions

Insertion of proximal VP shunt catheter by trans fontanelle US

Trans fontanelle US Guided VP Shunt

Eligibility Criteria

Age5 Days - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients who are diagnosed with congenital Hydrocephalus
  • age of patients : \< 2 years with patent Anterior Fontanelle
  • Not operated with frontal shunt before

You may not qualify if:

  • patients who are diagnosed with congenital Hydrocephalus
  • age of patients : \< 2 years with patent Anterior Fontanelle
  • Not operated with frontal shunt before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 33242372BACKGROUND
  • Sarikaya-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.

    PMID: 38917967BACKGROUND
  • Kullmann 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.

    PMID: 29167995BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Mohamed Elsayed Mohamed Elsayed, Prof

CONTACT

Ali Ahmed Ali abdel aleem, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 29, 2024

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

October 29, 2024

Record last verified: 2024-10