Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
NCT ID: NCT05960669
Last Updated: 2023-07-27
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2018-08-01
2022-08-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improvement of RARP Outcomes Via 3D Printed/Virtual Prostate Models
NCT05982418
Robotic Athermal Nerve-Sparing Radical Prostatectomy
NCT02079155
Transrectal Ultrasound Imaging of the Prostate Gland and Neurovascular Bundles During Robot-Assisted Laparoscopic Radical Prostatectomy
NCT00952666
Partial Prostatectomy for Prostate Cancer
NCT06624813
3D Versus Robot Assisted Laparoscopic Prostatectomy.
NCT03550040
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR).
Objective:
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
Design, setting and participants:
100 patients with NS-RARP performed between September 2018 and August 2021 were included in this prospective multicenter cohort study.
Interventions:
A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a PSM and guide SR.
Outcome Measurements and statistical analysis Endpoints were comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status. Secondary parameters for oncological and erectile outcomes were assessed before and one year after surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
3D model guided SR
A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection.
3D model guided secondary resection
A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3D model guided secondary resection
A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* suitable pelvic MRI for the creation of a personalized 3D prostate model,
* written patient consent
Exclusion Criteria
18 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Intuitive Surgical
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian CE Engesser, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Jan JE Ebbing, PD Dr. med
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätsspital Basel Urologie
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AURORA_2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.