To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.
Sutter Health - 1101 Van Ness Ave
San Francisco, California, United States
Human Factors as assessed using the frequency of failure
The design of the Poseidon System meets all acceptance criteria for design validation. User is able to operate device per the instructions for use. This criterion will be assessed in a pass/fail manner with an allowance of only 1 failure in the first 15 subjects and 1 failure in the second 15 subjects (if applicable).
Time frame: 1 day
Colonoscope Control as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
User shall not adversely influence typical actuation of a scope during colonoscopy procedure as assessed using a 5-point Likert scale.
Time frame: 1 day
Device Usability 1 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
User assessment of functional acceptability of Poseidon device ratchet location as assessed using a 5-point Likert scale.
Time frame: 1 day
Device Usability 2 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
User assessment of functional acceptability of Poseidon device intergluteal cleft fit as assessed using a 5-point Likert scale
Time frame: 1 day
Fluid retention as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
The Poseidon System shall minimize passage of fluids through and around the scope lumen when a scope is in the device, as assessed using a 5-point Likert scale.
Time frame: 1 day
Number of Adverse Events
Safety defined as the occurrence of all adverse events measured from the Index Procedure through the 2 Week Post Procedure Follow-up Visit.
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Time frame: 2 weeks
Time measured in minutes
Procedure time measured in minutes from the point of scope insertion to the point of scope removal (scope-in / scope-out).
Time frame: 1 day
Number of Device Deficiencies
Device deficiencies defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance including malfunctions, use errors, and inadequate labelling.
Time frame: 1 day