Clinical trial NCT05864040: HYbrid RObotic Surgery in Urology
Official title: HYROS (HYbrid RObotic Surgery in Urology)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrectomy
Keywords: Radical
Simple
Laparoscopy
Lead sponsor: Rob Surgical Systems S.L.
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety of the Bitrack System
timeFrame: 30 days post-procedure
measure: Performance of the Bitrack System
timeFrame: During the procedure
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Procedure, discharge (up to one week post-procedure), 14 days and 30 days follow-up
measure: Number of Participants With Absence of Tissue Damage
timeFrame: During the procedure
measure: Individual Performance of Surgical Instruments
timeFrame: During the procedure
measure: Blood Loss
timeFrame: During the procedure
measure: Transfusion Rates
timeFrame: During the procedure
measure: Number of Participants That Require Hemostatic Agents.
timeFrame: During the procedure
measure: Operative Time Procedure
timeFrame: During the entire surgical procedure
measure: Post-operative Pain
timeFrame: Day 1 and Day 2 post-procedure
measure: Length of Stay (LoS) in Hospital
timeFrame: Discharge (up to one week post-procedure)
measure: Patient Pain Assessment
timeFrame: Discharge (up to one week post-procedure), 14- and 30-days post-procedure
measure: Post-procedure Complication Rates - Comprehensive Complication Index (CCI)
timeFrame: Discharge (up to one week post-procedure),14 and 30 days follow-up
measure: Post-procedure Complication Rates - Clavien-Dindo Classification
timeFrame: Discharge (up to one week post-procedure),14 and 30 days follow-up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Lluis Peri Cusi, MD
role: PRINCIPAL_INVESTIGATOR
References: