Status:
UNKNOWN
Pituitary Gland Stimulation for Cancer Pain Relief
Lead Sponsor:
Leiden University Medical Center
Conditions:
Oncology Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients will undergo an implantation of an extradural pituitary surface electrode in the pituitary fossa. The electrode will be attached to a neurostimulator via which the patient will receive up to ...
Eligibility Criteria
Inclusion
- Adult patient
- 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
- Not fit for general anesthesia
- 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
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05230238
Start Date
October 12 2021
End Date
January 1 2024
Last Update
March 10 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Leiden University Medical Center
Leiden, Netherlands