Post Market surveillance Registry to evaluate safety and effectiveness of Medtronic Market released products in real-world practice.

Not Applicable

Recruiting

• Conditions: Other specified disorders of urinary system,

• Registration Number: CTRI/2021/09/036295
• Lead Sponsor: Medtronic Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-26
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the overall complication rate through 30 days in patients undergoing surgery with the Medtronic Robotic Assisted Surgical Device (RASD)	30 days
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Apollo Hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Care Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Paras Hospital; 🇮🇳 Gurgaon, HARYANA, India

Venkateshwar Hospital; 🇮🇳 Delhi, DELHI, India

Apollo Hospitals

🇮🇳Chennai, TAMIL NADU, India

Dr Venkatesh Munikrishnan

Principal investigator

9677000400

venky247@gmail.com