PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 23:23:32 GMT)

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 Trial Public Title of Study Versius Clinical Study Scientific Title of A PROSPECTIVE CLINICAL STUDY TO EVALUATE THE SAFETY AND PERFORMANCE OF Study THE VERSIUS SURGICAL ROBOTIC SYSTEM Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Dhananjay Kelkar Trial Coordinator (multi-center study) Designation Principal Investigator Affiliation Deenanath Mangeshkar Hospital & Research Centre Address Deenanath Mangeshkar Hospital & Research Centre,Erandwane 411004 Phone 02040151000 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Dhananjay Kelkar Query) Designation Principal Investigator Affiliation Deenanath Mangeshkar Hospital & Research Centre Address Deenanath Mangeshkar Hospital & Research Centre,Erandwane Pune MAHARASHTRA 411004 India Phone 02040151000 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Manisha Jadhav Designation Clinical Manager Affiliation CMR Surgical Address B-S1, Mathura One, N.H. 17, Porvorim, Bardez North GOA 403521 India Phone 09623243509 Fax Email [email protected]

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Source of Monetary or Source of Monetary or Material Support Material Support > Versius - Surgical Robotic System by CMR Surgical. Local partner is Indical Medsurg Pvt Ltd Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Dhananjay Kelkar Deenanath Mangeshkar Erandawane 02040151000 Hospital Pune MAHARASHTRA [email protected] Dr Raj Nagarkar HCG Manavata Cancer HCG Manavata Cancer 09823061929 Centre Centre, Nashik Near Mylan Circle, Mumbai drraj@manavatacancer Naka, Nashik, centre.com Maharashtra 422002 Nashik MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Committee Approved 30/11/2020 No Downtown Hospital Ethics Committee, Rao Approved 11/08/2020 No Nursing Home, Pune Institutional Ethics Approved 23/02/2019 No Committee DMH RC Manavata Clinical Approved 11/10/2019 No Research Institute Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Cholelithiasis Patients Diseases of appendix Patients Other noninflammatory disorders ofcervix uteri Patients Salpingitis and oophoritis Intervention / Type Name Details Comparator Agent Intervention Versius - A Surgical Robotic Robotic Assisted Surgeries System Comparator Agent Not Applicable Not Applicable Inclusion Criteria 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

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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. Exclusion Criteria Exclusion Criteria 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 Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Rate of unplanned conversion of procedures to Hopsitalisation Visit other MAS or open surgery Secondary Outcome Outcome Timepoints The following parameters will be collected during Study duration 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 Target Sample Size Total Sample Size=270 Sample Size from India=270 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 15/03/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=2 Days=20 Recruitment Status of Open to Recruitment Trial (Global)

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Recruitment Status of Open to Recruitment Trial (India) Publication Details 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

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