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Robot surgeon takes on kidney and prostate operations
NCT ID NCT06119568
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This trial evaluates the Bitrack robotic system, designed to assist surgeons during laparoscopic kidney removal (partial or total) and prostate removal. The study includes 15 adults scheduled for these surgeries. The goal is to check if the robot works safely and effectively, as rated by the surgeon.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bitrack System, a robotic surgical device used for laparoscopic kidney and prostate surgeries
- What this could lead to
- If successful, this robotic system could offer a safe and effective option for minimally invasive kidney and prostate surgeries.
- What could go wrong
- This is a small, early-stage study with only 15 participants, so results may not apply broadly. The system could fail or cause complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Apr 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult subjects between 18 and 90 years old who have provided written informed consent prior to any clinical investigation related procedures. 2. Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria. 3. Ability and willingness to comply with all study requirements to be evaluated for each study visit. Exclusion Criteria: 1. Pregnant or breastfeeding women at the time of the surgery. 2. Subjects with severe concomitant illness that, at PI´s discretion, increases risk of therapeutic interventions or that have been submitted to multiple prior surgeries. 3. Subjects admitted to the hospital due to an emergency situation. 4. Subjects with untreated active infection. 5. Subject with known allergy to some of the device components (i.e., stainless steel, etc.) 6. Subjects not suitable to undergo MIS/MIRS, according to medical criteria. 7. Subjects with life expectancy inferior to 3 months. 8. Subjects with a BMI ≥ 40. 9. Subjects with any contraindication for the use of the Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use. 10. Subjects with abuses of active substances or with uncontrolled psychiatric disorders. 11. Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations. 12. Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system. 13. Inability to adhere to study-related procedures. 14. Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
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