FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073750 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Borns Robotic Surgery System Clinical Study 
Scientific Title of Study   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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CTP-IND-20230610 V1.3 Dated 23 May 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek Bindal 
Designation  HEAD OF THE DEPARTMENT 
Affiliation  Max Super Speciality Hospital Vaishali 
Address  Max institute of minimal access bariatric & robotic surgery 4th floor tower 1 room no 4 max super speciality hospital vaishali a unit of crosslay remedies limited
w 3 sector 1 Vaishali Ghaziabad 201012
Ghaziabad
UTTAR PRADESH
201012
India 
Phone  9999931958  
Fax    
Email  bindal.vivek@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Bindal 
Designation  Head of the Department 
Affiliation  Max Super Speciality Hospital Vaishali 
Address  Max institute of minimal access bariatric & robotic surgery 4th floor tower 1 room no 4 max super speciality hospital vaishali a unit of crosslay remedies limited
W-3, Sector-1, Vaishali, Ghaziabad
Ghaziabad
UTTAR PRADESH
201012
India 
Phone  9999931958  
Fax    
Email  bindal.vivek@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Bindal 
Designation  Head of the Department 
Affiliation  Max Super Speciality Hospital Vaishali 
Address  Max institute of minimal access bariatric & robotic surgery 4th floor tower 1 room no 4 max super speciality hospital vaishali a unit of crosslay remedies limited
W-3, Sector-1, Vaishali, Ghaziabad 201012
Ghaziabad
UTTAR PRADESH
201012
India 
Phone  9999931958  
Fax    
Email  bindal.vivek@gmail.com  
 
Source of Monetary or Material Support  
Devki Devi Foundation 2 press enclave road saket New delhi India 110017 
 
Primary Sponsor  
Name  Devki Devi Foundation 
Address  2 Press Enclave Road Saket New Delhi 110017 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pawanindra Lal  Maulana azad medical college & Associated lok nayak hospital new delhi110002  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi,
New Delhi
DELHI 		 9891209609

profplal@gmail.com 
Dr vivek bindal  Max Speciality Hospital Vaishali  Max super speciality hospital vaishali w3 sector 1 vaishali Ghaziabad ,Max institute of minimal access bariatric & robotic surgery 4th floor tower 1 room no 4
Ghaziabad
UTTAR PRADESH 		 99999-31958

bindal.vivek@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Max Super Specialty Hospital, Vaishali, A unit of Crosslay Remedies Ltd. Address: Max Super Specialty Hospital, Vaishali, A unit of Crosslay Remedies Ltd W-3, Sector-1, Vaishali, Ghaziabad-201012, Utter Pradesh, India   Approved 
Institutional Ethisc Committee Maulana Azad Medical College Campus, 2 Bahadur Shah Zafar Marg, Maulana Azad Medical College Campus, New Delhi, Central Delhi Delhi 110002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BMR-5000 Surgical Robot  The main system includes Surgical Cart, Control Console, Lens Drive Robot, Tool Drive Robot, and Equipment Cabinet. The main system operates the robotic instrument to complete the operation. The intended use of the BMR-5000 Surgical Robot is for precise control of key technical operations such as tissue clipping, sharp dissection, blunt dissection, tissue exposure, cutting, suturing, hemostasis, and digestive tract reconstruction in minimally invasive surgery. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 isunwilling or unable to comply with the doctors 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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The incidence of complications related to the test device that meet the Clavien Dindo grading system level III a or higher criteria from the first incision to 14 or 30 days after surgery depending on the type of surgery.
 		 Visit 1 Screening Period
Visit 2 Operation Period (Day 0).
Visit 3 24 hours after surgery.
Visit 4: postoperative follow-up (day 7±2) on-site or by phone.
Visit 5: postoperative follow-up (Group A: day 14±2, Group B: day 30±5).
 
 
Secondary Outcome  
Outcome  TimePoints 
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 & stability.
 		 Visit 1 Screening Period
Visit 2 Operation Period (Day 0).
Visit 3 24 hours after surgery.
Visit 4: postoperative follow-up (day 7±2) on-site or by phone.
Visit 5: postoperative follow-up (Group A: day 14±2, Group B: day 30±5). 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/09/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.
 
Close