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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bitrack System-assisted laparoscopic radical/simple nephrectomy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lluis Peri Cusi, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age at enrolment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | adverse events | 30 days post-procedure |
|
From baseline to 30-days post-procedure.
All Adverse Events during the procedure and through the 14- and 30-days post-procedure were assessed. The relationship with the investigational device and/or procedure was examined by the Principal Investigator and reported to the Sponsor.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaume Amat, CEO | Rob Surgical Systems | +34 93 013 08 83 | jaume.amat@robsurgical.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2022 | Jan 17, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| C537984 | Charcot-Marie-Tooth disease, Type 1C |
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| ID | Term |
|---|---|
| D009392 | Nephrectomy |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Number of Participants With Absence of Tissue Damage | Individual safety is defined as absence of unwanted injure of any tissue for each instrument. | 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. | During the procedure |
| Blood Loss | Blood Loss defined as estimated mL of blood loss | During the procedure |
| Transfusion Rates | Transfusion rate as the number of participants that required blood transfusion | During the procedure |
| Number of Participants That Require Hemostatic Agents. | Number of participants that require the use of hemostatic agents. | 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. | 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:
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. | 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. | 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'). | 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). | 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. | Discharge (up to one week post-procedure),14 and 30 days follow-up |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | During the procedure |
|
|
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| 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. | Posted | Count of Participants | Participants | Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up |
|
|
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| Secondary | Number of Participants With Absence of Tissue Damage | Individual safety is defined as absence of unwanted injure of any tissue for each instrument. | Posted | Count of Participants | Participants | During the procedure |
|
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|
| 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. | Posted | Mean | Standard Deviation | score on a scale | During the procedure |
|
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| Secondary | Blood Loss | Blood Loss defined as estimated mL of blood loss | Posted | Mean | Standard Deviation | mL | During the procedure |
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| Secondary | Transfusion Rates | Transfusion rate as the number of participants that required blood transfusion | Posted | Count of Participants | Participants | During the procedure |
|
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| Secondary | Number of Participants That Require Hemostatic Agents. | Number of participants that require the use of hemostatic agents. | Posted | Count of Participants | Participants | During the procedure |
|
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| 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. | Posted | Mean | Standard Deviation | minutes | During the entire surgical procedure |
|
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| 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:
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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 2 post-procedure |
|
|
|
| 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. | Posted | Mean | Standard Deviation | days | Discharge (up to one week post-procedure) |
|
|
|
| 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'). | Posted | Mean | Standard Deviation | score on a scale | Discharge (up to one week post-procedure), 14- and 30-days post-procedure |
|
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| 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). | Posted | Mean | Standard Deviation | score on a scale | Discharge (up to one week post-procedure),14 and 30 days follow-up |
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| 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. | Posted | Count of Participants | Participants | Discharge (up to one week post-procedure),14 and 30 days follow-up |
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| Severe AE |
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| Device-related AE |
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| Procedure-related AE |
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| Other AE according to relationship to the study |
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