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

Colonic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05512026
• Other study ID #: CLIN-0100
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2022
• Source: WAE Medical
• Contact: IRENE LI
• Phone: 415-600-5848
• Email: Irene.Li[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Sutter Health - 1101 Van Ness Ave	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
WAE Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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