- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02255890
Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device
Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device; A Multi-Center, International Registry to Evaluate the Treatment of Prostate Cancer in Terms of Recurrence, Functional Outcomes and Safety.
Study Overview
Status
Conditions
Detailed Description
This is an international prospective observational multi-center study in which data on consecutive patients for 5 years with prostate cancer who undergo IRE are collected. Data from each patient will be collected at participating centers over a 5-year period. Patients' data at baseline visit (pre-IRE), peri-operative data and follow up for 5 years will be recorded. Follow up data will be collected according to the following schedule:
1 - 2 weeks after surgery
- st year: every 3 months
- nd year: every three months
- rd year: every 6 months
- th and 5th year: once a year. Data from participating centers will be collected through electronic Case Report Forms (eCRFs), with use of an online Data Management System (DMS), which is located and maintained at the CROES Office. The data collection or patient participation in this study does not interfere with the choice of treatment, sample collection, procedures and the treatment itself, which should entirely follow standard hospital practices, including the follow up.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Amsterdam, Netherlands, 1105AZ
- AMC University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Is diagnosed with histologically confirmed prostate cancer
- Is scheduled for IRE Nanoknife®
- Has signed informed consent form
Exclusion Criteria:
- No specific exclusion criteria are defined.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to establish which indications lead to treatment with IRE Nanoknife® setting
Time Frame: 5 years
|
5 years
|
safety assessment measured by number of complications and adverse events
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Investigators
- Study Chair: Jean de la Rosette, Clinical Research Office of the Endourological Society
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Registry IRE Nanoknife®
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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