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A Prospective, PreMarket, Multi center, Nonsignificant Risk Study to Validate the Performance of the Poseidon TM System for Fluid Management During Water aided Colonoscopy. The Poseidon Trial CLIN0100

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How to fill out a prospective pre-market multicenter

01

Identify the target market for the product

02

Develop a protocol outlining the objectives, methodology, and participants for the multicenter study

03

Obtain approval from all participating centers and relevant regulatory bodies

04

Recruit and train investigators at each center to ensure standardized data collection

05

Monitor the progress of the study and collect and analyze data according to the protocol

Who needs a prospective pre-market multicenter?

01

Medical device manufacturers looking to gather data on the safety and efficacy of their product prior to market launch

02

Regulatory bodies requiring evidence of a product's safety and effectiveness before granting market approval

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What is a prospective pre-market multicenter?

A prospective pre-market multicenter study is a clinical trial conducted at multiple research sites to assess the safety and effectiveness of a medical device before it is approved for marketing.

Who is required to file a prospective pre-market multicenter?

Medical device manufacturers are required to file a prospective pre-market multicenter study to obtain approval for marketing their device.

How to fill out a prospective pre-market multicenter?

To fill out a prospective pre-market multicenter study, the manufacturer must submit a detailed study protocol, informed consent forms, and other relevant documentation to the regulatory authorities.

What is the purpose of a prospective pre-market multicenter?

The purpose of a prospective pre-market multicenter study is to gather data on the safety and effectiveness of a medical device in a real-world setting before it is made available to the general public.

What information must be reported on a prospective pre-market multicenter?

The information that must be reported on a prospective pre-market multicenter study includes patient demographics, device performance data, adverse events, and study outcomes.

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