Transcutaneous port (T-Port) for gastrostomy use in combination with Duodopa.

Transcutaneous port (T-Port) for gastrostomy use in combination with Duodopa. - T-Port and Duodopa

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30462

Enrollment

Registered

2007-09-13

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Parkinson's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clinical diagnosis of advanced Parkinson's disease. On/off phenomena leading to severe disability which can not be regulated by the normal oral drug schemes. A clinical indaction for duodenum Duodopa tretament should have been made by the treating physician.

Exclusion criteria

Exclusion criteria: non-responsiveness to levodopa substitution therapy. Deformities abdominal wall.

Design outcomes

Primary

Measure	Time frame
Safety: To assess the safety and tolerability: * Adverse event monitoring. * Tolerability assessed by number of subjects who complete the 6 months of treatment * Acceptance of the T-Port by the patients In addition: • Physical examination, including weight. • Vital signs systolic/diastolic blood pressure and pulse rate. • Concomitant medication usage. • Monitoring complications of the infusion device. Utility: Utility will be assessed using the UPDRS, TRS (treatment rating scale) and PDQ-8	—

Measure

Time frame

Safety: To assess the safety and tolerability: * Adverse event monitoring. * Tolerability assessed by number of subjects who complete the 6 months of treatment * Acceptance of the T-Port by the patients In addition: • Physical examination, including weight. • Vital signs systolic/diastolic blood pressure and pulse rate. • Concomitant medication usage. • Monitoring complications of the infusion device. Utility: Utility will be assessed using the UPDRS, TRS (treatment rating scale) and PDQ-8

—

Secondary

Measure	Time frame
NvT	—

Countries

Netherlands

Outcome results