Trial Outcomes & Findings for Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP (NCT NCT06119568)

NCT ID: NCT06119568

Last Updated: 2026-07-20

Results Overview

Evaluation of Bitrack System to assist in the accurate control of its compatible ESE/NESE instruments, during the intervention without causing any particular SAE related to the use of the medical devices under investigation.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

During the procedure

Results posted on

2026-07-20

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).: Three different surgery interventions: 1. Radical Nephrectomy: Complete remove of the kidney; 2. Partial Nephrectomy: Partial remove of a section in the kidney. 3. Radical Prostatectomy: Complete remote of the prostate gland. During each of these procedures removal of regional lymph nodes (lymphadenectomy) and lysis of abdominal lesions may be performed according to patient medical condition and/or surgeon criteria.
Overall Study STARTED	15
Overall Study COMPLETED	15
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	Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories n=15 Participants Robot assisted laparoscopic surgery Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP). During each of these procedures removal of regional lymph nodes (lymphadenectomy) and/or lysis of abdominal lesions could be performed according to patient medical condition and/or surgeon criteria.
Age, Continuous	64.9 years STANDARD_DEVIATION 13.0 • n=15 Participants
Sex: Female, Male Female	4 Participants n=15 Participants
Sex: Female, Male Male	11 Participants n=15 Participants
BMI	26.1 kg/m2 STANDARD_DEVIATION 3.68 • n=15 Participants
Procedure Type Radical Nephrectomy	9 Participants n=15 Participants
Procedure Type Partial Nephrectomy	1 Participants n=15 Participants
Procedure Type Radical Prostatectomy	5 Participants n=15 Participants

PRIMARY outcome

Timeframe: During the procedure

Outcome measures

Outcome measures
Measure	Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories n=15 Participants Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).: Three different surgery interventions: 1. Radical Nephrectomy: Complete remove of the kidney; 2. Partial Nephrectomy: Partial remove of a section in the kidney. 3. Radical Prostatectomy: Complete remote of the prostate gland. During each of these procedures removal of regional lymph nodes (lymphadenectomy) and lysis of abdominal lesions may be performed according to patient medical condition and/or surgeon criteria.
Lack of Occurrence of a SAE Related to the Use of the Medical Devices Under Investigation During the Intervention	0 serious adverse events

PRIMARY outcome

Timeframe: During the procedure

Estimation of the global performance score: Assessment with a "Surgeon performance scale", that ranges with the minimum score of 1 (Failure) and the maximun score of 5 (Excellent), to confirm that the Bitrack system and ESE/NESE instruments perform as intended during the surgery. This scale is measured by the surgeon after each surgery.

Outcome measures

Outcome measures
Measure	Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories n=15 Participants Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).: Three different surgery interventions: 1. Radical Nephrectomy: Complete remove of the kidney; 2. Partial Nephrectomy: Partial remove of a section in the kidney. 3. Radical Prostatectomy: Complete remote of the prostate gland. During each of these procedures removal of regional lymph nodes (lymphadenectomy) and lysis of abdominal lesions may be performed according to patient medical condition and/or surgeon criteria.
Performance	4.04 Score on a scale Interval 3.85 to 4.24

Adverse Events

Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Surgically Treated With Bitrack System and ESE/ NESE Instruments and Accessories n=15 participants at risk Robot assisted laparoscopic Radical/simple nephrectomy (RN), Partial nephrectomy (PN) or Radical Prostatectomy (RP).: Three different surgery interventions: 1. Radical Nephrectomy: Complete remove of the kidney; 2. Partial Nephrectomy: Partial remove of a section in the kidney. 3. Radical Prostatectomy: Complete remote of the prostate gland. During each of these procedures removal of regional lymph nodes (lymphadenectomy) and lysis of abdominal lesions may be performed according to patient medical condition and/or surgeon criteria.
Nervous system disorders Vagal Syndrome	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Vascular disorders Bleeding through drainage injury	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Renal and urinary disorders Urinary Incontinence	26.7% 4/15 • Number of events 4 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Gastrointestinal disorders Dysphagia	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Renal and urinary disorders Urinary tenesmus like discomfort	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Gastrointestinal disorders Constipation	20.0% 3/15 • Number of events 3 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
General disorders Fever	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Vascular disorders Intergrappa bleeding	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Nervous system disorders Pre-syncope	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Renal and urinary disorders Urinary Tract Infection	13.3% 2/15 • Number of events 2 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Vascular disorders Hypotensive episode	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
General disorders Oedema	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Renal and urinary disorders Haematuria	13.3% 2/15 • Number of events 2 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Gastrointestinal disorders Abdominal discomfort	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Gastrointestinal disorders Pneumoperitoneum	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Vascular disorders Hemathoma	13.3% 2/15 • Number of events 2 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Skin and subcutaneous tissue disorders Glans Injury	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.
Renal and urinary disorders Urine retention	6.7% 1/15 • Number of events 1 • 30 days No Serious Adverse Events (SAE) or deaths were observed.

Additional Information

Mireia Riera

Rob Surgical

Phone: 0034930130883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place