MULTICENTER / OPEN-LABEL / NON-INTERVENTIONAL PMCF STUDY OF THE PERFORMANCE AND SAFETY OF XABO® Catheters IN PATIENTS SUFFERING FROM THE FOLLOWING CONDITION: Hydrocephalus of any aetiology

MULTICENTER / OPEN-LABEL / NON-INTERVENTIONAL PMCF STUDY OF THE PERFORMANCE AND SAFETY OF XABO® Catheters IN PATIENTS SUFFERING FROM THE FOLLOWING CONDITION: Hydrocephalus of any aetiology - PMCF-Study XABO®

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036116

Enrollment

117

Registered

2025-03-13

Start date

2023-10-16

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malabsorptive hydrocephalus, posthemorrhagic hydrocephalus, hemispherectomy, Arachnoidalcyst, Spina bifida, Hydrocephalus in meningomyelocele G91.1 G91.0 G91.2 G91.3 Q03.0 Q03.1 Q07.0 G93.2

Interventions

Group 1: The study participants receive a shunt with an antibiotic-impregnated catheter (XABO®) as part of standard and routine treatment. Only 38 days after implantation, a review is carried out to d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who get an antibiotic-impregnated catheter XABO® implanted

Exclusion criteria

Exclusion criteria: - Infections in the implantation area - Pathological concentration values (e.g. of blood components and/or protein) in the CSF - Intolerance to materials of the shunt system - Hypersensitivity to rifampicin and/or clindamycin hydrochloride - Combinations with shunt components from other manufacturers

Design outcomes

Primary

Measure	Time frame
Revision of the XABO® catheter due to an infection within the first 38 days after implantation	—

Secondary

Measure	Time frame
All other reasons for the revision	—

Countries

Germany

Contacts

Public ContactFlorian Drubel

Christoph Miethke GmbH & Co. KG

studies@miethke.com+49 331 62083-4440

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026