Evaluation of Prostate Cancer Margins
Sponsor
Intuitive Surgical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05317143
Collaborator
(none)
100
1
14.2
7
Study Details
Study Description
Brief Summary
Pathological assessment of prostate tissue
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of Prostate Cancer Margins
Actual Study Start Date
:
Feb 22, 2022
Anticipated Primary Completion Date
:
Dec 31, 2022
Anticipated Study Completion Date
:
Apr 30, 2023
Outcome Measures
Primary Outcome Measures
- Positive Margin [Immediately postoperatively, expected same day as surgery]
Detection of positive margin
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosed with prostate cancer
-
Subject must be scheduled for robotic-assisted radical prostatectomy at the clinical site.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Antonius Hospital, Prostatazentrum Nordwest | Gronau | Germany | 48599 |
Sponsors and Collaborators
- Intuitive Surgical
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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT05317143
Other Study ID Numbers:
- 1091459C
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: