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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Colonic Disease
• Intervention / Treatment: Device: Feasibility Assessment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94109
      • Sutter Health - 1101 Van Ness Ave
      • Contact: Laura Nguyen; Email: Laura.Nguyen@sutterhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients 18 years of age or greater.
2. Patients that have an indication to undergo water-aided colonoscopy.
3. 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:

1. Subject unable or unwilling to provide informed consent.
2. Subjects with prolapsing hemorrhoids that require intervention or hemorrhoids that have been treated within last 3 months.
3. Prior TAMIS (Trans-anal minimally invasive surgery) or TEMS (Trans-anal micro endoscopic surgery).
4. 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.
5. 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.
6. Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feasibility Assessment; 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; To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: WAE Medical
• Investigators: Principal Investigator: Andrew Nettt, MD, Sutter Health

Study record dates

Study Major Dates

• Study Start (Anticipated): September 12, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: CLIN-0100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not applicable to this trial. Trial and device validation will be used to commercially release product only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes