| CTRI Number |
CTRI/2022/09/045789 [Registered on: 22/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Versius Clinical Study in Robot Assisted Total Hysterectomy |
|
Scientific Title of Study
|
Prospective Clinical Study to Evaluate the Safety and Efficacy of the
Versius Surgical System in Robot-Assisted Hysterectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajnish Nagarkar |
| Designation |
Surgical Oncologist |
| Affiliation |
HCG Manavata Cancer Centre |
| Address |
HCG Manavata Cancer Centre, Behind Shivang auto, Mumbai Naka Nashik, Maharashtra, India
Nashik
MAHARASHTRA
422002
India |
| Phone |
9823061929 |
| Fax |
|
| Email |
drraj@manavatacancercentre.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Jadhav |
| Designation |
Operations Manager |
| Affiliation |
CMR Surgical India Pvt Ltd |
| Address |
CMR Surgical India Pvt Ltd.
Ground Floor, Navelcar Pride, Kadamba Plateau NH-4A, Chimbel Tiswadi, North Goa, Goa, 403006
North Goa
GOA
403006
India |
| Phone |
9623243509 |
| Fax |
|
| Email |
manisha.jadhav@cmrsurgical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Jadhav |
| Designation |
Operations Manager |
| Affiliation |
CMR Surgical India Pvt Ltd |
| Address |
CMR Surgical India Pvt Ltd.
Ground Floor, Navelcar Pride, Kadamba Plateau NH-4A, Chimbel Tiswadi, North Goa, Goa, 403006
North Goa
GOA
403006
India |
| Phone |
9623243509 |
| Fax |
|
| Email |
manisha.jadhav@cmrsurgical.com |
|
|
Source of Monetary or Material Support
|
| Versius - Surgical Robotic System by CMR Surgical. Local partner is Indical Medsurg Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
CMR Surgical India Pvt Ltd |
| Address |
CMR Surgical India Pvt Ltd.
Ground Floor, Navelcar Pride, Kadamba Plateau NH-4A, Chimbel Tiswadi, North Goa, Goa, 403006
|
| Type of Sponsor |
Other [Privet Limited Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raj Nagarkar |
HCG Manavata Cancer Centre |
HCG Manavata Cancer Centre, Nashik Near Mylan Circle, Mumbai Naka, Nashik, Maharashtra 422002
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
09823061929
drraj@manavatacancercentre.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Versius - A Surgical Robotic System |
Preoperative Screening
Intraoperative Hospital Stay
Postoperative Follow up DIscharge Day
Postoperative Follow up Day 42±2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient deemed suitable for total laparoscopic hysterectomy
procedure using Versius Surgical Robotic System
2. Patients able to provide written informed consent to
participate in the study (with help of appropriate legal
representatives if required)
3. Female, aged 18 years or above
4. Female of childbearing potential, must not be pregnant
5. Patients with BMI ≤40. Ideally BMI ≥25 to ≤ 40 |
|
| ExclusionCriteria |
| Details |
1. Patient participation in an investigational clinical study within 30
days before screening
2. Inability or difficulties to provide informed consent
3. Oncological cases, patients undergoing surgery or treatment for
malignant disease
4. Patients who fall into American Society of Anaesthesiologists (ASA)
Class IV or above (Appendix B)
5. Uterus size of > 14 weeks
6. History of chronic alcohol or drug abuse
7. Chronic renal failure or on dialysis
8. Significant medical history or immunocompromised
9. Subjects with any other clinically significant unstable medical
disorder, life-threatening disease, or anything else in the opinion
of the Investigator which would contra-indicate a surgical procedure
10. Patient tested COVID positive within last 30 days of screening
11. Patient tested COVID positive within 48 hours within procedure
12. Diabetes mellitus (Glycemia > 11mmol/L; >200 mg/dL)
13. Uncontrolled hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Efficacy Outcome:
Efficacy will be measured by the rate of successful completion of the procedures as planned (i.e., without
unplanned conversion to other laparoscopic or open surgery).
Primary Safety Outcome:
Safety will be measured by the rate of incidence of serious adverse events up to 30 days following the procedure. |
Primary Efficacy Outcome:
Efficacy will be measured by the rate of successful completion of the procedures as planned (i.e., without
unplanned conversion to other laparoscopic or open surgery).
Primary Safety Outcome:
Safety will be measured by the rate of incidence of serious adverse events up to 30 days following the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Endpoints:
• Operative time – From skin incision to skin closure
• Estimated blood loss (intra-operative)
• Blood transfusion (during hospitalization)
• Intra-operative complications
• Return to operating room within 24 hours
• Length of hospital stay
• Readmission to hospital within 30 days
• Reoperation within 30 days
• Mortality rate at 30 days
• Vaginal Vault healing at 42 days post-operative
• Histopathology of surgically removed specimen
• Device deficiencies and use errors regardless of relationship to an adverse event
• All Adverse Events
• Device performance data including unplanned instrument usage, clashes, collision detection, alarms. |
• Vaginal Vault healing at 42 days post-operative |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Title:Prospective Clinical Study to Evaluate the Safety and Efficacy of the
Versius Surgical System in Robot-Assisted Total Hysterectomy
Objective: To evaluate the Safety and Efficacy of the Versius Surgical Robotic System in
robotically assisted total hysterectomy (RATH) surgical procedures. Measured by
incidence of serious adverse events and successful completion of the surgery
without conversion to laparoscopic or open surgery, respectively.
Study Design: A prospective cohort study as Preoperative
Screening>Intraoperative
Hospital Stay>Postoperative
Follow up
DIscharge Day>Postoperative
Follow up
Day 42±2
Product: The Versius Surgical Robotic System (Versius®)
Study Population: Patients suitable for Robot assisted- minimal access total hysterectomy surgeries
using Versius® (as determined by the Principal Investigator), above 18 years of age.
Procedure Type: Minimal access Robot-Assisted Total Hysterectomy procedures
Primary Efficacy
Outcome:
Rate of successful completion of robotic assisted surgery without unplanned
conversion to other laparoscopic or open surgery
Primary Safety
Outcome:
Incidence of Serious Adverse Events up to 30 days post operation
Secondary Outcomes: 1. Operative time – From incision to skin closure 2. Estimated blood loss (intra-operative) 3. Blood transfusion (intra-operative) 4. Intra-operative complications 5. Return to operating room within 24 hours 6. Length of hospital stay 7. Readmission to hospital within 30 days 8. Reoperation within 30 days 9. Mortality rate at 30 days 10. Vaginal Vault healing at 42 days post-operative 11. Histopathology of surgically removed specimen 12. Device deficiencies and use errors regardless of relationship to an
adverse event 13. All Adverse Events 14. Device performance data including unplanned instrument usage, clashes,
collision detection, alarms. |