| CTRI Number |
CTRI/2019/02/017872 [Registered on: 28/02/2019] Trial Registered Prospectively |
| Last Modified On: |
07/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Versius Clinical Study |
Scientific Title of Study
Modification(s)
|
A PROSPECTIVE CLINICAL STUDY TO EVALUATE THE SAFETY AND PERFORMANCE OF THE VERSIUS SURGICAL ROBOTIC SYSTEM |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhananjay Kelkar |
| Address |
Deenanath Mangeshkar Hospital & Research Centre,Erandwane
Pune
MAHARASHTRA
411004
India |
| Phone |
02040151000 |
| Fax |
|
| Email |
dskelkar@gmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr Dhananjay Kelkar |
| Address |
Deenanath Mangeshkar Hospital & Research Centre,Erandwane
Pune
MAHARASHTRA
411004
India |
| Phone |
02040151000 |
| Fax |
|
| Email |
dskelkar@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
Manisha Jadhav |
| Address |
B-S1, Mathura One, N.H. 17, Porvorim, Bardez
North Goa
GOA
403521
India |
| Phone |
09623243509 |
| Fax |
|
| Email |
manisha.jadhav@cmrsurgical.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Versius - Surgical Robotic System by CMR Surgical. Local partner is Indical Medsurg Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
CMR Surgical Limited |
| Address |
Unit 2, Crome Lea Business Park, Madingley Road, CB23 7PH, UK. |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhananjay Kelkar |
Deenanath Mangeshkar Hospital |
Erandawane
Pune
|
02040151000
dskelkar@gmail.com |
| Dr Raj Nagarkar |
HCG Manavata Cancer Centre |
HCG Manavata Cancer Centre, Nashik Near Mylan Circle, Mumbai Naka, Nashik, Maharashtra 422002
Nashik
|
09823061929
drraj@manavatacancercentre.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee Downtown Hospital |
Approved |
| Ethics Committee, Rao Nursing Home, Pune |
Approved |
| Institutional Ethics Committee DMH RC |
Approved |
| Manavata Clinical Research Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cholelithiasis |
| Patients |
Diseases of appendix |
| Patients |
Other noninflammatory disorders ofcervix uteri |
| Patients |
Salpingitis and oophoritis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Versius - A Surgical Robotic System |
Robotic Assisted Surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient deemed suitable for at least one of the surgical procedures using Versius
2. Patients (or appropriate legal representatives) able to provide written and audio-visual informed consent to participate in the study
3. Male or female, aged between 18 and 65 years old
4. If female of childbearing potential, must not be pregnant and agree to not become pregnant for the duration of the study. |
|
| ExclusionCriteria |
| Details |
1. Patient participation in an investigational clinical study within 30 days before screening
2. Inability to provide informed consent
3. Uncontrolled hypertension and/or diabetes mellitus
4. Patients who fall into New York Heart Association (NYHA) Class III or IV (Appendix B)
5. Incidence of metastases, regional and/or distant
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of unplanned conversion of procedures to other MAS or open surgery |
Hopsitalisation Visit |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The following parameters will be collected during the study:
Operative time – from incision to skin closure
Estimated blood loss (intra-operative)
Blood transfusion (intra-operative)
Return to operating room within 24 hours
Length of hospital stay
Readmission to hospital within 30 days
Intra-operative complications
Post-operative complications through 90 days, reported using Clavien-Dindo Classification (Dindo, 2004) (Appendix D)
90 day mortality |
Study duration |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/03/2019 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet |
|
Brief Summary
|
STUDY TITLE: A prospective clinical study to evaluate the safety and performance of the Versius Surgical Robotic System
OBJECTIVE: To evaluate the safe use and performance of the Versius Surgical Robotic System in robotically-assisted surgery across multiple surgical procedures
STUDY DESIGN: A prospective cohort study in line with the Stage 2a and 2b IDEAL collaboration recommendations: Stage 2a IDEAL: 30 patients Stage 2b IDEAL: 240 patients
PRODUCT: The Versius Surgical Robotic System (Versius)
DEVICE RISK Medical Device Regulations: Class IIb CLASSIFICATION: US FDA: Class II General Controls
STUDY POPULATION: All patients suitable for at least one of the minimal access surgery (MAS) listed below using Versius (as determined by the Principal Investigator), aged between 18 to 65 years old
PROCEDURE TYPES: Minimal access surgical procedures listed below: Stage 2a IDEAL: minor gynaecological surgical procedures from salpingectomy (unilateral or bilateral), salpingo-oophorectomy, unilateral or bilateral oophorectomy, and ovarian cystectomy for benign disease and minor general surgical procedure appendectomy Stage 2b IDEAL: gynaecological surgical procedure: total laparoscopic hysterectomy +/- unilateral or bilateral salpingo-oophorectomy and general surgical procedure: cholecystectomy |
