Evaluation of Prostate Cancer Margins
April 7, 2025 updated by: Intuitive Surgical
Pathological assessment of prostate tissue
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gronau, Germany, 48599
- St. Antonius Hospital, Prostatazentrum Nordwest
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with prostate cancer who undergo robotic-assisted prostatectomy
Description
Inclusion Criteria:
- Diagnosed with prostate cancer
- Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Margin
Time Frame: Immediately postoperatively, expected same day as surgery
|
Detection of positive margin
|
Immediately postoperatively, expected same day as surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jörn Hinrich Witt, PD Dr. med, St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany
- Principal Investigator: Sami-Ramzi Leyh-Bannurah, PD Dr. med, St. Antonius, Hospital, Prostatazentrum Nordwest, Möllenweg 22, 48599 Gronau, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2022
Primary Completion (Actual)
November 10, 2022
Study Completion (Actual)
November 10, 2022
Study Registration Dates
First Submitted
February 2, 2022
First Submitted That Met QC Criteria
April 4, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Actual)
April 9, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1091459C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.