Trial Outcomes & Findings for HYbrid RObotic Surgery in Urology (NCT NCT05864040)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

30 days post-procedure

Results posted on

2025-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Age, Customized Subject 01	53 years n=3 Participants
Age, Customized Subject 02	49 years n=3 Participants
Age, Customized Subject 03	37 years n=3 Participants
Sex: Female, Male Female	1 Participants n=3 Participants
Sex: Female, Male Male	2 Participants n=3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Safety of the Bitrack System PRAEs through 30 days	0 adverse events
Safety of the Bitrack System SAEs through 30 days	0 adverse events

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Performance of the Bitrack System Surgery successfully completed with the Bitrack System	3 Participants
Performance of the Bitrack System Conversion to open surgery	0 Participants
Performance of the Bitrack System Conversion to laparoscopic surgery	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Number of Participants With Adverse Events Adverse Event (AE) reported	0 Participants
Number of Participants With Adverse Events Mild AE	0 Participants
Number of Participants With Adverse Events Moderate AE	0 Participants
Number of Participants With Adverse Events Severe AE	0 Participants
Number of Participants With Adverse Events Device-related AE	0 Participants
Number of Participants With Adverse Events Procedure-related AE	0 Participants
Number of Participants With Adverse Events Other AE according to relationship to the study	0 Participants

SECONDARY outcome

Timeframe: During the procedure

Individual safety is defined as absence of unwanted injure of any tissue for each instrument.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Number of Participants With Absence of Tissue Damage	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Individual Performance of Surgical Instruments	7.33 score on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: During the procedure

Blood Loss defined as estimated mL of blood loss

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Blood Loss	183.33 mL Standard Deviation 125.83

SECONDARY outcome

Timeframe: During the procedure

Transfusion rate as the number of participants that required blood transfusion

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Transfusion Rates	0 Participants

SECONDARY outcome

Timeframe: During the procedure

Number of participants that require the use of hemostatic agents.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Number of Participants That Require Hemostatic Agents.	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Operative Time Procedure	123.6 minutes Standard Deviation 40.79

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Post-operative Pain Day 1	4.67 units on a scale Standard Deviation 3.78
Post-operative Pain Day 2	3.33 units on a scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Length of Stay (LoS) in Hospital	2.33 days Standard Deviation 0.58

SECONDARY outcome

Timeframe: 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').

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Patient Pain Assessment Discharge	4 score on a scale Standard Deviation 1.73
Patient Pain Assessment Day 14	1 score on a scale Standard Deviation 0
Patient Pain Assessment Day 30	0.67 score on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Post-procedure Complication Rates - Comprehensive Complication Index (CCI) Discharge	0 score on a scale Standard Deviation 0
Post-procedure Complication Rates - Comprehensive Complication Index (CCI) Day 14	0 score on a scale Standard Deviation 0
Post-procedure Complication Rates - Comprehensive Complication Index (CCI) Day 30	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy n=3 Participants 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.
Post-procedure Complication Rates - Clavien-Dindo Classification Subject 01	NA Participants No post-procedure complications were reported, and therefore classification was not applicable
Post-procedure Complication Rates - Clavien-Dindo Classification Subject 02	NA Participants No post-procedure complications were reported, and therefore classification was not applicable
Post-procedure Complication Rates - Clavien-Dindo Classification Subject 03	NA Participants No post-procedure complications were reported, and therefore classification was not applicable

Adverse Events

Bitrack System-assisted Laparoscopic Radical/Simple Nephrectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jaume Amat, CEO

Rob Surgical Systems

Phone: +34 93 013 08 83

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place