Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2021-10-12
2024-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pituitary stimulation
Patients will receive pituitary stimulation as oncology pain treatment.
Pituitary gland stimulation
Pituitary gland stimulation via an surface electrode connected to an external neurostimulator
Interventions
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Pituitary gland stimulation
Pituitary gland stimulation via an surface electrode connected to an external neurostimulator
Eligibility Criteria
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Inclusion Criteria
* In palliative phase of metastatic disease, without options for further systemic treatment or radiotherapy
* Inadequately controlled pain with standard care
* Most prominent part of experienced pain is nociceptive
* Karnofsky Performance Score ≥30
Exclusion Criteria
* Pregnancy
* Unfavorable local anatomy for PGS, due to a disease process, or anatomical configuration
* Clinical signs of posterior pituitary gland disfunction
* Recent history of alcohol or drug abuse
* Severe immunodeficiency
* Need for anticoagulation therapy that cannot be abrogated for surgery
* Need for subsequent MRI-imaging
* Cognitive impairments prohibiting full understanding of study and ability to provide informed consent
* Not able to adequately communicate in Dutch or English
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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wrvanfurth
neurosurgeon
Principal Investigators
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Wouter van Furth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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Leiden University Medical Center
Leiden, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Wouter van Furth, MD, PhD
Role: primary
Other Identifiers
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P21.036
Identifier Type: -
Identifier Source: org_study_id
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