NCT05512026

Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy

A Prospective, Pre-Market, Multicenter, Non-significant Risk Study to Validate the Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: WAE Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.

Detailed description

The Poseidon System is a fluid management system that is investigationally indicated to provide a pathway to control waste fluid during irrigation of the colon. The Poseidon device is a manually placed and controlled device that provides support and sealing on the perimeter of an endoscope while managing fluids naturally exiting the anus, during a colonoscopy procedure. The device consists of a introducer and hand piece that allows for passage of an endoscope with valves and a retention balloon that minimize fluid passage with a single-use waste bag for collecting fluid and debris. The Poseidon™ System is not yet FDA 510(k) cleared.

Conditions

• Colonic Disease

Interventions

Type	Name	Description
DEVICE	Feasibility Assessment	To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.

Timeline

• Start date: 2022-09-12
• Primary completion: 2023-01-31
• Completion: 2023-03-31
• First posted: 2022-08-23
• Last updated: 2022-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study