Borns Robotic Surgery System Clinical Study

Completed

Conditions: Diseases of the digestive system, (2) ICD-10 Condition: E65-E68||Overweight, obesity and other hyperalimentation,

Registration Number: CTRI/2023/03/050470

Lead Sponsor: Max Hospital Vaishali

Brief Summary: Trial Title - Pilot Study Clinical Trial to Evaluate the Safety and Efficacy of Robotic Surgery System for Minimum Access Surgical Procedures

Design - This study applies a single-center, single-arm clinical trial design, to include 20 subjects. Subjects who met the inclusion criteria of this study will be enrolled in the study for surgical treatment using the device.

Site - Max Super Speciality Hospital, Vaishali (A Unit of Crosslay Remedies Limited)

Sample Size - 20 Cases and the specific procedures are Cholecystectomy (5 cases), appendectomy or abdominal hernia repair (5 cases), gastrointestinal surgery (10 cases) including, bariatric surgery, and gastrointestinal tumors surgery.

Scope - Patients who meet the indications for general surgery and intend to undergo minimally invasive surgery. (Such as cholecystectomy, appendectomy or abdominal hernia repair, gastrointestinal tumor, etc.)Indications - This device is used for precise control of key technical operations such as tissue clipping, sharp dissection, blunt dissection, tissue level exposure, cutting, suturing, hemostasis, nerve exposure, and protection, and digestive tract reconstruction in minimally invasive surgery, and assists in the completion of general surgery Minimally invasive surgery, etc.

Purpose - This clinical investigation plan specifies a Pilot Study Clinical Trial to evaluate the efficacy and safety of a laparoscopic robotic surgical system produced by Borns Medical Robotics Inc., for minimally invasive surgery operations. The main clinical safety and efficacy evaluation endpoint of this trial is defined as: Primary Safety Outcome - Incidence of adverse events, serious adverse events, and complications (i.e., surgery-related adverse events, device defects)

Primary Efficacy Outcome - Rate of successful completion of robotic assisted surgery without unplanned conversion to laparoscopic/open surgery.

Secondary Efficacy Evaluation - operation time, intraoperative blood loss, device performance, physical status score (ECOG), cost analysis, etc.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients who meet the surgical indications and need minimally invasive cholecystectomy, appendectomy, abdominal hernia repair, bariatric or gastrointestinal surgery.Volunteered to participate in this trial and signed the informed consent.

Exclusion Criteria

Those who cannot tolerate or establish pneumoperitoneum.
Severe heart, lung, liver, and kidney disease who cannot tolerate surgery.
Those who need emergency surgery due to illness.
History of continuous systemic corticosteroid or immunosuppressive therapy within the past 1 mon.
The patient is mentally incapable to understand the requirements and consequences of the study.
Pregnant and lactating women.
The patient is unwilling or unable to comply with the doctor orders.
Those who have participated in clinical trials within the past three months.
Extremes of age (Less than 18 years or more than 75 years) 10.
Other conditions deemed inappropriate by the PI and medical staff.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical success rate, which is the rate between the cases completed without unplanned change in surgical treatment (such as conversion to conventional laparoscopic /open surgery) and the total number of cases.	Before surgery (Day -30) \| Operation period (Day 0) \| 24 hours after surgery \| Postoperative (Day 3) \| Postoperative (Day 7) \| After surgery (Day 14) \| Postoperative (Day 30)
Incidence of adverse events, serious adverse events, and complications (i.e., surgery-related adverse events, device defects)	Before surgery (Day -30) \| Operation period (Day 0) \| 24 hours after surgery \| Postoperative (Day 3) \| Postoperative (Day 7) \| After surgery (Day 14) \| Postoperative (Day 30)

Secondary Outcome Measures

Name	Time	Method
operation time, intraoperative blood loss, device performance, physical status score (ECOG), cost analysis, etc.	Operation period (Day 0)

Trial Locations

Locations (1): Max Speciality Hospital Vaishali
🇮🇳
Ghaziabad, UTTAR PRADESH, India
Max Speciality Hospital Vaishali
🇮🇳Ghaziabad, UTTAR PRADESH, India
Dr Vivek Bindal
Principal investigator
bindal.vivek@gmail.com