NephrectomyHYROSNCT05864040
HYbrid RObotic Surgery in Urology
A study testing Bitrack System-assisted laparoscopic radical/simple nephrectomy in people with Nephrectomy, run by Rob Surgical Systems S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nephrectomy
- What is being tested?
- Bitrack System-assisted laparoscopic radical/simple nephrectomy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HYROS (HYbrid RObotic Surgery in Urology)
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.
Read the detailed description
The Bitrack System is a surgical robot indicated to be used during urological surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic manipulation.
Robotic Assisted Surgical (RAS) systems and equipment such as Bitrack System are intended for use in invasive surgical procedures, during which patients are potentially most vulnerable to physical harm. The Bitrack System comprises a console, a robotic unit, and embedded software.
The HYROS clinical investigation will be conducted as a single-center, early feasibility, and first-in-human (FIH) clinical investigation with a single arm, open-label, and non-randomized design, that will include 3 patients. This clinical investigation aims to evaluate the safety and performance of the Bitrack System in patients indicated with robotic-assisted laparoscopic Radical/simple nephrectomy surgery.
The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 14-Days Follow-up visit, and 30-Days Follow-up visit (remote). The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic radical/simple nephrectomy. The total duration of the clinical investigation is expected to be 4 months, consisting of approximately 3 months of enrollment plus 1 month of follow-up. The end of the clinical investigation will occur when the last visit of the last enrolled subject is completed.
- Conditions
- Nephrectomy
- Being tested
- Bitrack System-assisted laparoscopic radical/simple nephrectomy
- Keywords
- Radical, Simple, Laparoscopy
- Medical subject headings
- Charcot-Marie-Tooth disease, Type 1C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bitrack System-assisted laparoscopic radical/simple nephrectomyDevice
Robot-Assisted Laparoscopic Transperitoneal Radical/Simple Nephrectomy is performed under general anesthesia. Using blunt dissection, the inferior pole of the kidney is lifted, and ureter and gonadal veins released from fat and connective tissue. The ureter is dissected caudally and sectioned after being sealed with a distal endoscopic clip. Dissection proceeds along the psoas muscle with anterior elevation of the ureter and lower renal pole towards the hilium. Main hilar are circumferentially dissected and sectioned and the kidney is entirely mobilized and released. Gerota´s capsule and suprarenal gland may be preserved if oncologically safe. Once the specimen is completely released, a laparoscopic bag is introduced by the assistant and the specimen entrapped. The robot is undocked, gas evacuated from the abdomen and specimen retrieved.
| Study group | Role | What they receive |
|---|---|---|
| Subjects to undergo laparoscopic radical/simple nephrectomy | Experimental | Adult subjects between 18 and 90 years old, that provided informed consent prior to any clinical investigation-related procedure, who have been scheduled for a laparoscopic radical/simple nephrectomy surgery and who are able and willing to comply with all study requirements to be evaluated for each study visit. Receives: Device: Bitrack System-assisted laparoscopic radical/simple nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Bitrack System
Evaluation of the safety of the Bitrack System by measuring the occurrence of Procedure-Related Adverse Events (PRAEs) and Serious Adverse Events (SAEs) during the procedure and through the 30 days post-procedure period of enrolled patients indicated for robot assisted laparoscopic radical/simple nephrectomy. PRAEs are defined as any AE related to the investigational procedure.
Measured: 30 days post-procedure
Performance of the Bitrack System
Evaluation of the performance of the investigational device by means of its ability to access and reach the target zone, perform all relevant surgical tasks and to be withdrawn efficiently without conversion to minimally invasive surgery (MIS) or open surgery. The performance of the Bitrack System and the ESE/NESE instruments is analyzed through the conversion rate to conventional laparoscopy/open surgery.
Measured: During the procedure
Secondary outcomes (12)
Number of Participants With Adverse Events
All AE(s) events during the procedure and through the 14 and 30 days post-procedure were also assessed, including the assessment of the relationship with the investigational device and/or procedure by the principal investigator.
Measured: Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up
Number of Participants With Absence of Tissue Damage
Individual safety is defined as absence of unwanted injure of any tissue for each instrument.
Measured: During the procedure
Individual Performance of Surgical Instruments
Individual performance is assessed by the Visual Analogue Scale (ranging from 0 to 10) following the subjective surgeon's opinion for each instrument surgical function, being 0 a non-functional tool and 10 an instrument that works exactly equivalent to the surgeon/s hands.
Measured: During the procedure
Blood Loss
Blood Loss defined as estimated mL of blood loss
Measured: During the procedure
Transfusion Rates
Transfusion rate as the number of participants that required blood transfusion
Measured: During the procedure
Number of Participants That Require Hemostatic Agents.
Number of participants that require the use of hemostatic agents.
Measured: During the procedure
Operative Time Procedure
Operative Time Procedure (or Surgical Procedure Time) includes the time spend to perform the set of all the different tasks completed during the surgical procedure. It is defined from first ESE/NESE instruments docking to the conversion to gestural mode for their final withdrawal.
Measured: During the entire surgical procedure
Post-operative Pain
Evaluation of the post-operative pain in patients through the Cumulative Analgesic Consumption Score (CACS) during the first week (7days) post-procedure.
To calculate the CACS score, information on the number of single analgesic doses (n) and their classification on the WHO pain relief ladder was collected. The WHO pain relief ladder ranges from I to III:
- step I (nonopioids): acetaminophen, ibuprofen or metamizole;
- step II (opioids for mild to moderate pain): tramadol, tilidine/naloxone;
- step III (opioids for moderate to severe pain): piritramide, pethidine, oxycodone or morphine.
The Cumulative Analgesic Consumption Score (CACS) is calculated by adding all (n), multiplied by the level of the WHO pain relief ladder.
Since the lenght of stay was shorter (2-3 days), it was not possible to collect the analgesic consumption up to 7 days after patient hospital discharge.
Measured: Day 1 and Day 2 post-procedure
Length of Stay (LoS) in Hospital
Assessment of the duration of subject's hospitalization as the Length of Stay (LoS) in hospital calculated from day of admission to day of discharge.
Measured: Discharge (up to one week post-procedure)
Patient Pain Assessment
Patient pain assessment via Visual Analog Score (VAS) for pain on a scale from 0 ('no pain') to 10 ('pain as bad as it could possibly be').
Measured: Discharge (up to one week post-procedure), 14- and 30-days post-procedure
Post-procedure Complication Rates - Comprehensive Complication Index (CCI)
Post-procedure complication rates assessment by measuring the Comprehensive Complication Index (CCI) on a scale from 0 (no complications) to 100 (death).
Measured: Discharge (up to one week post-procedure),14 and 30 days follow-up
Post-procedure Complication Rates - Clavien-Dindo Classification
Post-procedure complication rates assessment by the Clavien-Dindo classification, which consists of 7 grades (I, II, IIIa, IIIb, Iva, Ivb and V), the first one (I) indicating any deviation from the normal postoperative course and the highest (V) corresponding to death.
Measured: Discharge (up to one week post-procedure),14 and 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start11 Apr 2023
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rob Surgical Systems S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lluis Peri Cusi, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864040
- Sponsor's protocol ID
- PL-PR01-027
- Acronym
- HYROS
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2023
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYROS (HYbrid RObotic Surgery in Urology)
- ClinicalTrials.gov ID
- NCT05864040
- Acronym / sponsor ID
- HYROS / PL-PR01-027
- Conditions
- Nephrectomy
- Keywords
- Radical, Simple, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rob Surgical Systems S.L.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Bitrack System is a surgical robot indicated to be used during urological surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic manipulation.
Robotic Assisted Surgical (RAS) systems and equipment such as Bitrack System are intended for use in invasive surgical procedures, during which patients are potentially most vulnerable to physical harm. The Bitrack System comprises a console, a robotic unit, and embedded software.
The HYROS clinical investigation will be conducted as a single-center, early feasibility, and first-in-human (FIH) clinical investigation with a single arm, open-label, and non-randomized design, that will include 3 patients. This clinical investigation aims to evaluate the safety and performance of the Bitrack System in patients indicated with robotic-assisted laparoscopic Radical/simple nephrectomy surgery.
The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 14-Days Follow-up visit, and 30-Days Follow-up visit (remote). The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic radical/simple nephrectomy. The total duration of the clinical investigation is expected to be 4 months, consisting of approximately 3 months of enrollment plus 1 month of follow-up. The end of the clinical investigation will occur when the last visit of the last enrolled subject is completed.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects to undergo laparoscopic radical/simple nephrectomy | Experimental | Device: Bitrack System-assisted laparoscopic radical/simple nephrectomyAdult subjects between 18 and 90 years old, that provided informed consent prior to any clinical investigation-related procedure, who have been scheduled for a laparoscopic radical/simple nephrectomy surgery and who are able and willing to comply with all study requirements to be evaluated for each study visit. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bitrack System-assisted laparoscopic radical/simple nephrectomyRobot-Assisted Laparoscopic Transperitoneal Radical/Simple Nephrectomy is performed under general anesthesia. Using blunt dissection, the inferior pole of the kidney is lifted, and ureter and gonadal veins released from fat and connective tissue. The ureter is dissected caudally and sectioned after being sealed with a distal endoscopic clip. Dissection proceeds along the psoas muscle with anterior elevation of the ureter and lower renal pole towards the hilium. Main hilar are circumferentially dissected and sectioned and the kidney is entirely mobilized and released. Gerota´s capsule and suprarenal gland may be preserved if oncologically safe. Once the specimen is completely released, a laparoscopic bag is introduced by the assistant and the specimen entrapped. The robot is undocked, gas evacuated from the abdomen and specimen retrieved. | Device | Subjects to undergo laparoscopic radical/simple nephrectomy |
Primary outcome
Safety of the Bitrack System
Time frame: 30 days post-procedure
Evaluation of the safety of the Bitrack System by measuring the occurrence of Procedure-Related Adverse Events (PRAEs) and Serious Adverse Events (SAEs) during the procedure and through the 30 days post-procedure period of enrolled patients indicated for robot assisted laparoscopic radical/simple nephrectomy. PRAEs are defined as any AE related to the investigational procedure.
Performance of the Bitrack System
Time frame: During the procedure
Evaluation of the performance of the investigational device by means of its ability to access and reach the target zone, perform all relevant surgical tasks and to be withdrawn efficiently without conversion to minimally invasive surgery (MIS) or open surgery. The performance of the Bitrack System and the ESE/NESE instruments is analyzed through the conversion rate to conventional laparoscopy/open surgery.
12 secondary outcomes
Number of Participants With Adverse Events
Time frame: Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up
Number of Participants With Absence of Tissue Damage
Time frame: During the procedure
Individual Performance of Surgical Instruments
Time frame: During the procedure
Blood Loss
Time frame: During the procedure
Transfusion Rates
Time frame: During the procedure
Number of Participants That Require Hemostatic Agents.
Time frame: During the procedure
Operative Time Procedure
Time frame: During the entire surgical procedure
Post-operative Pain
Time frame: Day 1 and Day 2 post-procedure
Length of Stay (LoS) in Hospital
Time frame: Discharge (up to one week post-procedure)
Patient Pain Assessment
Time frame: Discharge (up to one week post-procedure), 14- and 30-days post-procedure
Post-procedure Complication Rates - Comprehensive Complication Index (CCI)
Time frame: Discharge (up to one week post-procedure),14 and 30 days follow-up
Post-procedure Complication Rates - Clavien-Dindo Classification
Time frame: Discharge (up to one week post-procedure),14 and 30 days follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Nephrectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruitingObservational study
Hugo™ RAS Urology Post-Market Clinical Study
Prostatectomy, Cystectomy
Active, not recruitingPhase 2
Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma
Immune Checkpoint Inhibitors, Cytoreductive Nephrectomy
Active, not recruitingPhase 2
NSAID Use After Robotic Partial Nephrectomy
Kidney Cancer, Renal Cancer
Recruiting
Effect of Non-Clamping and Sutureless Technique on Postoperative Renal Function in Robot-Assisted Partial Nephrectomy
Renal Neoplasms, Localized Kidney Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lluis Peri Cusi, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bitrack System-assisted laparoscopic radical/simple nephrectomy in people with Nephrectomy, run by Rob Surgical Systems S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Bitrack System (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.