N/A
N=3
HYbrid RObotic Surgery in Urology
Nephrectomy
Bottom Line
View on ClinicalTrials.gov: NCT05864040 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Safety of the Bitrack System — 0; 0 adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bitrack System-assisted laparoscopic radical/simple nephrectomy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rob Surgical Systems S.L.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of the Bitrack System |
0; 0 | — |
| PRIMARY Performance of the Bitrack System |
3; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Absence of Tissue Damage |
3 | — |
| SECONDARY Individual Performance of Surgical Instruments |
7.33 | — |
| SECONDARY Blood Loss |
183.33 | — |
| SECONDARY Transfusion Rates |
— | — |
| SECONDARY Number of Participants That Require Hemostatic Agents. |
— | — |
| SECONDARY Operative Time Procedure |
123.6 | — |
| SECONDARY Post-operative Pain |
4.67; 3.33 | — |
| SECONDARY Length of Stay (LoS) in Hospital |
2.33 | — |
| SECONDARY Patient Pain Assessment |
4; 1; 0.67 | — |
| SECONDARY Post-procedure Complication Rates - Comprehensive Complication Index (CCI) |
0; 0; 0 | — |
| SECONDARY Post-procedure Complication Rates - Clavien-Dindo Classification |
NA; NA; NA | — |
Summary
The HYbrid RObotic Surgery in urology (HYROS) study is an early feasibility clinical investigation of a new medical device under the commercial name of Bitrack System. Bitrack System is a surgical robot indicated to be used during urological surgical procedures. The Bitrack System also requires the specific single use of Electro-Surgical Endoscopic (ESE) instruments and Non-Electro Surgical Endoscopic (NESE) instruments.
The purpose of this clinical investigation is to evaluate the safety and feasibility of the Bitrack System and its corresponding ESE and NESE instruments in patients with the indication of a robot assisted laparoscopic radical/simple nephrectomy.
Eligibility Criteria
Inclusion Criteria
- Adult subjects between 18 and 90 years old
- Subjects must provide written informed consent prior to any clinical investigation related procedure
- Subjects who have been scheduled for a laparoscopic radical/simple nephrectomy surgery
- Ability and willingness to comply with all study requirements to be evaluated for each study visit
Exclusion Criteria
- Pregnant or breastfeeding women at the time of the surgery
- Inability to adhere to study-related procedures
- Subject has known allergy to some of the device components (i.e., stainless steel, etc.)
- Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow-up requirements
- Subjects not suitable to undergo MIS (Minimally Invasive Surgery) /MIRS (Minimally Invasive Robotic Surgery), according to medical criteria
- Subjects with life expectancy inferior to 3 months
- Subjects with a Body Mass Index (BMI) ≥ 40
- Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been submitted to multiple prior operations
- Subjects with abuses of active substances or with uncontrolled psychiatric disorders
- Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system
- Subjects with any contraindication for the use of the Bitrack System and the ESE/NESE instruments, as specified in the Instructions For Use
Data sourced from ClinicalTrials.gov (NCT05864040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.