The primary objective of this test series will be to gain experience and provide long-term safety using a transcutaneous titanium port as an access port for gastrostomy (T-Port) in the context of Duodopa treatment of severely afflicted PD patients.
ID
Bron
Verkorte titel
Aandoening
1. Parkinson's disease (NLD: ziekte van Parkinson);
2. T-Port;
3. Duodopa.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. To assess the safety and tolerability:<br>
a. Adverse event monitoring;<br>
b. Tolerability assessed by number of subjects who complete the 6 months of treatment;<br>
c. Acceptance of the T-Port by the patients;
<br><br>
In addition:<br>
2. Physical examination, including weight;<br>
3. Vital signs systolic/diastolic blood pressure and pulse rate;<br>
4. Concomitant medication usage;<br>
5. Monitoring complications of the infusion device.
Achtergrond van het onderzoek
This is an open study assessing the long-term safety and utility of a new gastrostomy access port for use with Duodopa, in patients in whom a positive test of the clinical response was already conducted with Duodopa administered via a nasoduodenal tube. Only those PD patients are eligible for the T-Port system who on clinical grounds will be proposed to have Duodopa therapy.
Doel van het onderzoek
The primary objective of this test series will be to gain experience and provide long-term safety using a transcutaneous titanium port as an access port for gastrostomy (T-Port) in the context of Duodopa treatment of severely afflicted PD patients.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Insertion in abdominal wall titanium T-Port en insertion of duodenum tube.
Publiek
K.L. Leenders
Groningen 9700 RB
The Netherlands
+31 50 361 2175
k.l.leenders@neuro.umcg.nl
Wetenschappelijk
K.L. Leenders
Groningen 9700 RB
The Netherlands
+31 50 361 2175
k.l.leenders@neuro.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Non-responsiveness to levodopa substitution therapy;
2. Deformities abdominal wall.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL910 |
| NTR-old | NTR934 |
| Ander register | METc : 2007/072 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |