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

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

Detailed Description
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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.

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

Conditions
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Colonic Disease

Intervention / Treatment
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* Device: Feasibility Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or greater. Patients that have an indication to undergo water-aided colonoscopy. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments. Exclusion Criteria: Subject unable or unwilling to provide informed consent. Subjects with prolapsing hemorrhoids that require intervention or hemorrhoids that have been treated within last 3 months. Prior TAMIS (Trans-anal minimally invasive surgery) or TEMS (Trans-anal micro endoscopic surgery). Any condition that in the opinion of the Investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Up to 30 subjects Fifteen subjects will be enrolled in this study and undergo water-aided colonoscopy with the Poseidon System. If the Primary Endpoint and Secondary Endpoint 1 are achieved in the first 15 subjects, the study will be complete. If the Primary Endpoint or Secondary Endpoint 1 are not achieved, changes to the device design will be made and this protocol will be conducted again in a second group of 15 subjects with updated device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility Assessment<br>The Poseidon System is investigational and indicated to provide a pathway to control waste fluid during irrigation of the colon. All consented patients will receive the Device use during their colonoscopy procedure. | Device: Feasibility Assessment<br>* To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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 | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 1 day |