Using a robotic system for kidney and prostate surgeries

HYbrid RObotic Surgery MulTiCentric Study (HYROS-MTC-I)

This study is testing whether a new robotic system can make kidney and prostate surgeries quicker and easier for 50 adults who need these operations.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Rob Surgical Systems S.L. (industry)
• Locations: 5 sites (Barcelona, Spain and 4 other locations)
• Trial ID: NCT06849271 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to evaluate the effectiveness of the ROB-Bitrack System in performing laparoscopic surgeries such as Radical Nephrectomy, Partial Nephrectomy, and Radical Prostatectomy. The study will involve 50 adult patients scheduled for these procedures and will assess whether the robotic system can reduce operative time compared to current minimally invasive surgical standards. It will be conducted across multiple centers with a single-arm, open-label design, and will include follow-up visits to monitor patient outcomes post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 who are scheduled for laparoscopic Radical Nephrectomy, Partial Nephrectomy, or Radical Prostatectomy.

Not a fit: Patients who are pregnant, have severe concomitant illnesses, or are unsuitable for minimally invasive surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to shorter operative times and improved surgical outcomes for patients undergoing kidney and prostate surgeries.

How similar studies have performed: Other studies have shown promising results with robotic-assisted surgeries, indicating potential for success with this novel approach.

Eligibility criteria

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 PrincipaI investigator´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 Minimally Invasive Surgery (MIS)/ Minimally Invasive Robotic Surgery (MIRS), according to medical criteria.
7. Subjects with life expectancy inferior to 3 months.
8. Subjects with a BMI (Body Mass Index) ≥ 40
9. Subjects with any contraindication for the use of the ROB-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

Where this trial is running

Barcelona, Spain and 4 other locations

• Hospital del Mar — Barcelona, Spain, Spain (RECRUITING)
• Hospital Clinic de Barcelona — Barcelona, Spain, Spain (RECRUITING)
• Hospital General de Granollers — Granollers, Spain, Spain (RECRUITING)
• Hospital de Mataró — Mataró, Spain, Spain (RECRUITING)
• Hospital Universitari de Vic — Vic, Spain, Spain (RECRUITING)

Study contacts

• Study coordinator: Jaume Amat CEO

Conditions: Nephrectomy, Prostatectomy, Radical nephrectomy, Partial nephrectomy, Radical prostatectomy, Lymphadenectomy, Lysis of adhesions, Robotic surgery