Nephrectomy
Conditions
Keywords
Radical, Simple, Laparoscopy
Brief 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.
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.
Interventions
DEVICEBitrack System-assisted laparoscopic radical/simple nephrectomy
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.
Sponsors
Rob Surgical Systems S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Bitrack System | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual Performance of Surgical Instruments | During the procedure | 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. |
| Blood Loss | During the procedure | Blood Loss defined as estimated mL of blood loss |
| Transfusion Rates | During the procedure | Transfusion rate as the number of participants that required blood transfusion |
| Number of Participants That Require Hemostatic Agents. | During the procedure | Number of participants that require the use of hemostatic agents. |
| Operative Time Procedure | During the entire surgical 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. |
| Number of Participants With Adverse Events | Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up | 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. |
| Length of Stay (LoS) in Hospital | Discharge (up to one week post-procedure) | 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. |
| Patient Pain Assessment | Discharge (up to one week post-procedure), 14- and 30-days post-procedure | 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'). |
| Post-procedure Complication Rates - Comprehensive Complication Index (CCI) | Discharge (up to one week post-procedure),14 and 30 days follow-up | Post-procedure complication rates assessment by measuring the Comprehensive Complication Index (CCI) on a scale from 0 (no complications) to 100 (death). |
| Post-procedure Complication Rates - Clavien-Dindo Classification | Discharge (up to one week post-procedure),14 and 30 days follow-up | 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. |
| Post-operative Pain | Day 1 and Day 2 post-procedure | 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. |
| Number of Participants With Absence of Tissue Damage | During the procedure | Individual safety is defined as absence of unwanted injure of any tissue for each instrument. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy 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. Robot-Assisted Laparoscopic Transperitoneal Radical/Simple Nephrectomy is performed under general anesthesia. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | — |
|---|---|---|
| Age, Customized Subject 01 | 53 years | — |
| Age, Customized Subject 02 | 49 years | — |
| Age, Customized Subject 03 | 37 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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.
Time frame: During the procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Performance of the Bitrack System | Surgery successfully completed with the Bitrack System | 3 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Performance of the Bitrack System | Conversion to open surgery | 0 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Performance of the Bitrack System | Conversion to laparoscopic surgery | 0 Participants |
Primary
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.
Time frame: 30 days post-procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Safety of the Bitrack System | PRAEs through 30 days | 0 adverse events |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Safety of the Bitrack System | SAEs through 30 days | 0 adverse events |
Secondary
Blood Loss
Blood Loss defined as estimated mL of blood loss
Time frame: During the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Blood Loss | 183.33 mL | Standard Deviation 125.83 |
Secondary
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.
Time frame: During the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Individual Performance of Surgical Instruments | 7.33 score on a scale | Standard Deviation 1.23 |
Secondary
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.
Time frame: Discharge (up to one week post-procedure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Length of Stay (LoS) in Hospital | 2.33 days | Standard Deviation 0.58 |
Secondary
Number of Participants That Require Hemostatic Agents.
Number of participants that require the use of hemostatic agents.
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants That Require Hemostatic Agents. | 0 Participants |
Secondary
Number of Participants With Absence of Tissue Damage
Individual safety is defined as absence of unwanted injure of any tissue for each instrument.
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Absence of Tissue Damage | 3 Participants |
Secondary
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.
Time frame: Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Adverse Events | Other AE according to relationship to the study | 0 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Adverse Events | Adverse Event (AE) reported | 0 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Adverse Events | Mild AE | 0 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Adverse Events | Moderate AE | 0 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Adverse Events | Severe AE | 0 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Adverse Events | Device-related AE | 0 Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Number of Participants With Adverse Events | Procedure-related AE | 0 Participants |
Secondary
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.
Time frame: During the entire surgical procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Operative Time Procedure | 123.6 minutes | Standard Deviation 40.79 |
Secondary
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').
Time frame: Discharge (up to one week post-procedure), 14- and 30-days post-procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Patient Pain Assessment | Discharge | 4 score on a scale | Standard Deviation 1.73 |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Patient Pain Assessment | Day 14 | 1 score on a scale | Standard Deviation 0 |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Patient Pain Assessment | Day 30 | 0.67 score on a scale | Standard Deviation 1.15 |
Secondary
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.
Time frame: Day 1 and Day 2 post-procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-operative Pain | Day 1 | 4.67 units on a scale | Standard Deviation 3.78 |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-operative Pain | Day 2 | 3.33 units on a scale | Standard Deviation 2.31 |
Secondary
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.
Time frame: Discharge (up to one week post-procedure),14 and 30 days follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-procedure Complication Rates - Clavien-Dindo Classification | Subject 01 | NA Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-procedure Complication Rates - Clavien-Dindo Classification | Subject 02 | NA Participants |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-procedure Complication Rates - Clavien-Dindo Classification | Subject 03 | NA Participants |
Secondary
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).
Time frame: Discharge (up to one week post-procedure),14 and 30 days follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-procedure Complication Rates - Comprehensive Complication Index (CCI) | Discharge | 0 score on a scale | Standard Deviation 0 |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-procedure Complication Rates - Comprehensive Complication Index (CCI) | Day 14 | 0 score on a scale | Standard Deviation 0 |
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Post-procedure Complication Rates - Comprehensive Complication Index (CCI) | Day 30 | 0 score on a scale | Standard Deviation 0 |
Secondary
Transfusion Rates
Transfusion rate as the number of participants that required blood transfusion
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy | Transfusion Rates | 0 Participants |