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

Phase 4

• Conditions: Health Condition 1: N398- Other specified disorders of urinary system

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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) <br/ ><br> <br/ ><br>Complications included in the primary objective are device and procedure related adverse events occurring to patients intra-operatively and post-operatively through 30 daysTimepoint: 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. <br/ ><br>Timepoint: 30 days