A prospective, multi-center, single-arm objective performance criteria clinical trial to evaluate the safety and efficacy of the robotic surgery system in general surgery.

Title- A prospective, multi-center, single-arm, objective performance criteria clinical trial to evaluate the safety and efficacy of the robotic surgery system in general surgery.

Indications- This medical device is expected to precisely control tissue clipping, sharp dissection, blunt dissection, tissue layer exposure, cutting, suture, hemostasis, nerve exposure and protection, reconstruction and other technical operations in minimally invasive procedure, and can assist in completing minimally invasive procedure in general surgery. The surgeon, who has received the professional training of this system, can complete the above operations in the operating room environment according to the specific procedures specified in the operating instructions.

Purposes- To evaluate the safety and efficacy of the clinical application of robotic surgical system by Borns Medical Robotics Inc., for minimally invasive surgery operations.

Design- This clinical investigation adopts a prospective multi-center, single-arm, objective performance criteria design of a clinical trial. This study will include 40subjects in addition to 20 already investigated in pilot study, the taol All consecutive subjects meeting the inclusion criteria of this investigation and agree to participate will be enrolled for surgical treatment using the device beginning the approval of the protocol.

Sites- Site 01: Max Super Speciality Hospital

Site 02: Maulana Azad Medical College (University of Delhi) & Associated Lok Nayak Hospital

Two hospitals who meet the qualification of national clinical trial institutions have been selected as sites of the clinical trial. One of them is a public hospital.

Sample Size- This pivotal study will enroll 40 subjects

Scope- Patients who meet the indications for general surgery (including benign and malignant lesions), such as gastro-intestinal surgery, bariatric surgery, hepatobiliary surgery, splenic surgery, abdominal hernia repair.

Inclusion criteria

1. Age 18 to 75 years (including 18 and 75 years).

2. Gender is not limited.

3. Patients who meet the indications for general surgery and are planned for laparoscopic/ endoscopic gastro-intestinal surgery, bariatric surgery, hepatobiliary surgery, splenic surgery, abdominal hernia repair are included in the study. Cholecystectomy/ CBD exploration Ventral and inguinal hernia repair Solid organ surgery (liver, spleen, adrenal) Sleeve gastrectomy

4. Volunteered to participate in this trial and signed the informed consent.

Exclusion criteria

1. Those who cannot tolerate or have established pneumoperitoneum.

2. Lymph node metastases fused and surrounded by important blood vessels.

3. Patients with extensive infiltration of tumor and surrounding tissues are not suitable for minimally invasive surgery.

4. Those with poor general condition that cannot be corrected despite preoperative treatment.

5. Severe heart, lung, liver, and kidney disease who cannot tolerate surgery.

6. Those who need emergency surgery due to illness.

7. History of continuous systemic corticosteroid or immunosuppressive therapy within the past 1 month.

8. The patient is mentally incapable or unable to understand the requirements of participating in the study.

9. Pregnant and lactating women.

10. The patient is unwilling or unable to comply with the doctor’s orders.

11. Those who have participated in clinical trials within the past three months.

12. Other conditions deemed inappropriate by the PI and medical staff.

Study Duration

The participation time of each subject is defined as the time from the subject’s consent to be enrolled in the trial to the end of the final follow-up. The expected duration of participation for each subject is around 30 days, having predefined visit and follow-up criteria. The entire research phase includes:

Visit 1: Screening Period (Day -30 ~ Day 0).

Visit 2: Operation Period (Day 0).

Visit 3: 24 hours after surgery.

Visit 4: Post-operative follow-up (Day 7±2). on-site or by phone.

Visit 5: Post-operative follow-up (Group A: Day 14±2, Group B: Day 30±5).

(Group A comprises the benign patients, and group B the malignant patients).

Clinical Evaluation Endpoints

The Primary Efficacy Endpoint

The success rate of operation (The non-conversion rate of operation):

The non-conversion rate of operation which is defined as not transitioning from the assisted method of the laparoscopic surgery system to other surgical instrument control systems, traditional laparoscopic surgery, or open surgery.

The Primary Safety Endpoint

The incidence of complications related to the test device that meet the Clavien Dindo grading system level III or higher criteria from the first incision to 14 or 30 days after surgery depending on the type of surgery.

Secondary Endpoint

The secondary endpoints of the study will encompass the following parameters: Surgical times, blood loss during intraoperative procedures, performance of the device along with the overall function and stability.

Statistical Analysis Plan

The lower bound of the success rate will be obtained by Clopper-Pearson method. The demographics and clinical features will be described by mean, standard deviation, median, IQR for quantitative characteristics and by count and percentages for qualitative characteristics. The follow-up measurements will be compared with baseline by paired method.