Actively Recruiting
HYbrid RObotic Surgery MulTiCentric Study
Led by Rob Surgical Systems S.L. · Updated on 2025-07-31
50
Participants Needed
5
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical investigation, HYROS-MTC-I, is to confirm the effectiveness of the combined use of ROB-Bitrack System, its corresponding ElectroSurgical Endoscopic instruments and Non-ElectroSurgical Endoscopic instruments (ESE and NESE instruments respectively) and accessories in a multicentric study in urologic procedures with the indication of a robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN), Radical Prostatectomy (RP or P), and when it applies Lysis of Adhesions (during a PN, RN or RP or P to cut the adhesions and reach the organ) and Lymphadenectomy (only after a P with the aim to remove the lymph nodes) . HYROS-MTC-I is a confirmatory study in which the hypothesis of the primary endpoint is that: "Operative time (OT) with Bitrack System and its ESE/NESE Instruments and accessories will be equal or lower than superiority margin time of State of the Art (SoTA) of MIRS (Minimally Invasive Robotic Surgery) independently of the user experience and site". This study includes the data collected up to 30 days post-surgery.
CONDITIONS
Official Title
HYbrid RObotic Surgery MulTiCentric Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between 18 and 90 years old who have given written informed consent.
- Scheduled for laparoscopic Radical/simple Nephrectomy, Partial Nephrectomy, or Radical Prostatectomy.
- Willing and able to follow all study requirements and attend all study visits.
You will not qualify if you...
- Pregnant or breastfeeding women at the time of surgery.
- Severe illnesses increasing surgical risk or multiple prior surgeries as judged by the investigator.
- Hospital admission due to emergency situations.
- Untreated active infections.
- Known allergies to device components such as stainless steel.
- Not suitable for Minimally Invasive or Robotic Surgery based on medical assessment.
- Life expectancy less than 3 months.
- Body Mass Index (BMI) of 40 or higher.
- Contraindications for use of the ROB-Bitrack System or its instruments per Instructions For Use.
- Substance abuse or uncontrolled psychiatric disorders.
- Severe heart or lung disease, bleeding disorders, or multiple previous operations.
- Scheduled for surgeries involving the heart, central circulatory system, or central nervous system.
- Unable to comply with study procedures.
- Participation in another clinical trial that could affect study outcomes or follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hospital del Mar
Barcelona, Spain, Spain, 08003
Actively Recruiting
2
Hospital Clinic de Barcelona
Barcelona, Spain, Spain, 08036
Actively Recruiting
3
Hospital General de Granollers
Granollers, Spain, Spain, 08402
Actively Recruiting
4
Hospital de Mataró
Mataró, Spain, Spain, 08304
Actively Recruiting
5
Hospital Universitari de Vic
Vic, Spain, Spain, 08500
Actively Recruiting
Research Team
J
Jaume Amat CEO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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