| CTRI Number |
CTRI/2021/09/036295 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Post Market surveillance Registry to evaluate safety and effectiveness of Medtronic Market released products in real-world practice. |
|
Scientific Title of Study
|
Product Surveillance Registry(PSR) |
| Trial Acronym |
PSR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT01524276 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt Ltd
Solitaire Corporate Park
Bldg No 12 6th Floor
Andheri Ghatkopar Link Road Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt Ltd
Solitaire Corporate Park
Bldg No 12 6th Floor
Andheri Ghatkopar Link Road Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Sr. Director Clinical Research and Medical Science Asia Region-Led Markets |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt Ltd
Solitaire Corporate Park
Bldg No 12 6th Floor
Andheri Ghatkopar Link Road Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| Medtronic Inc
Operational Headquarters
710 Medtronic Parkway
Fridley, MN U.S.A 55432 |
|
|
Primary Sponsor
|
| Name |
Medtronic Inc |
| Address |
Operational Headquarters
710 Medtronic Parkway
Fridley, MN U.S.A 55432 |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| India Medtronic Pvt Ltd |
1241, Solitaire Corporate Park, Building No 12, 4th Floor,
Andheri-Ghatkopar Link Road Mumbai MH 400093 India
|
|
|
Countries of Recruitment
|
Belgium
Chile
France
India
Spain |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venkatesh Munikrishnan |
Apollo Hospitals |
21 Off Greams Ln, Thousand Lights West, Thousand Lights, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU |
9677000400
venky247@gmail.com |
| Dr Manjula Anagani |
Care Hospitals |
Road Number 1, Prem Nagar, Banjara Hills
Hyderabad
TELANGANA |
7013976366
dr.manjula.anagani@carehospitals.com |
| Dr Meenakshi Sharma |
Paras Hospital |
C-1, Sushant Lok- 1,
Sector-43, Phase- I
Gurgaon
HARYANA |
9810794347
dmeenakshi9@gmail.com |
| Dr Ashish Sadana |
Venkateshwar Hospital |
Sector 12 Rd, Sector 18, Sector 18A Dwarka, Dwarka, New Delhi, Delhi 110075
New Delhi
DELHI |
9811611133
ashish.sadana@venkateshwarhospitals.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Commitee |
Approved |
| Institutional Ethics Commitee |
Approved |
| Venkateshwar Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N398||Other specified disorders of urinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Surgical Intervention |
Look in to safety and performance of Surgical intervention in Urology therapy with the help of robotic assisted surgical device. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
Patient has or is intended to receive or be treated with an eligible product (Section 3.3)
Patient is consented within the enrollment window of the treatment/therapy received, refer to the applicable Condition/Therapy Appendix.
|
|
| ExclusionCriteria |
| Details |
Patient who is, or is expected to be inaccessible for follow-up
Patient with exclusion criteria required by local law
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To demonstrate the overall complication rate through 30 days in patients undergoing surgery with the Medtronic Robotic Assisted Surgical Device (RASD)
Complications included in the primary objective are device and procedure related adverse events occurring to patients intra-operatively and post-operatively through 30 days |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective is intended to gain additional information about the safety and performance of the Medtronic RASD, to allow for data stratification and subgroup analysis and to assess learning curve. There will be no established performance goals related to the secondary objective.
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/06/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this registry is- Safety and efficacy of the Medtronic Robotic Assisted Surgical Device (RASD) demonstrated through pre-market Design Verification, Validation and Usability testing.
The purpose of the registry is to confirm clinical safety and performance of the RASD (Robotic-Assisted Surgical Device ) when used as intended in real-world setting. Data will be collected through Medtronic’s Post Market Surveillance platform, the Product Surveillance Registry (PSR), and be used for regulatory decision-making purposes. The PSR registry is global and India is one of the contribution nation for the real worlds data collection as mentioned above. |