| CTRI Number |
CTRI/2023/03/050470 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| 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
|
Pilot Study Clinical Trial to Evaluate the Safety and Efficacy of Robotic Surgery System for Minimum Access Surgical Procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CI/MD/2023/000005 |
DCGI |
| CTP-IND-20220924 (version: v1.0 date: 24/09/2022) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Bindal |
| Designation |
Head of Department |
| Affiliation |
Max Super Speciality Hospital Vaishali |
| Address |
Max Super Speciality Hospital, Vaishali
W-3, Sector-1, Vaishali, Ghaziabad 201012, Uttar Pradesh,India
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 Department |
| Affiliation |
Max Super Speciality Hospital Vaishali |
| Address |
Max Super Speciality Hospital, Vaishali W-3, Sector-1, Vaishali, Ghaziabad 201012, Uttar Pradesh,India
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9999931958 |
| Fax |
|
| Email |
bindal.vivek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Sharma |
| Designation |
Assistant Manager |
| Affiliation |
Max Hospital Vaishali |
| Address |
Office of Research, Max Hospital Vaishali
W-3, Sector-1, Vaishali, Ghaziabad, 201012, U.P.
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
91-7409382830 |
| Fax |
|
| Email |
Pawan.Sharma2@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Max Hospital Vaishali |
| Address |
Max Hospital Vaishali
W-3, Sector-1, Vaishali, Ghaziabad, 201012, U.P. |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Borns Medical Robotics Inc |
6325 Tucker Dr, San Jose, CA 95129 USA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Bindal |
Max Speciality Hospital Vaishali |
Department, Institute of Minimal Access, Bariatric and Robotic Surgery.
4th Floor tower 1 Room No 4 , Max Hospital Vaishali (A Unit of crosslay remedies limited)W-3, Sector-1, Vaishali, Ghaziabad, 201012, U.P.
Ghaziabad
UTTAR PRADESH |
91-99999-31958
bindal.vivek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Max Super Speciality Hospital, Vaishali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: E65-E68||Overweight, obesity and other hyperalimentation, |
|
|
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 |
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.
|
|
| ExclusionCriteria |
| Details |
1. Those who cannot tolerate or establish pneumoperitoneum.
2. Severe heart, lung, liver, and kidney disease who cannot tolerate surgery.
3. Those who need emergency surgery due to illness.
4. History of continuous systemic corticosteroid or immunosuppressive therapy within the past 1 mon. 5. The patient is mentally incapable to understand the requirements and consequences of the study.
6. Pregnant and lactating women.
7. The patient is unwilling or unable to comply with the doctor orders.
8. Those who have participated in clinical trials within the past three months.
9. Extremes of age (Less than 18 years or more than 75 years)
10. 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 |
Incidence of adverse events, serious adverse events, and complications (i.e., surgery-related adverse events, device defects)
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) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| operation time, intraoperative blood loss, device performance, physical status score (ECOG), cost analysis, etc. |
Operation period (Day 0)
24 hours after surgery
Postoperative (Day 3)
Postoperative (Day 7)
After surgery (Day 14)
Postoperative (Day 30) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2023 |
| Date of Study Completion (India) |
09/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |