Clinical trial NCT05512026: Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Disease
Lead sponsor: WAE Medical
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Human Factors as assessed using the frequency of failure
timeFrame: 1 day
measure: Colonoscope Control as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
timeFrame: 1 day
measure: Device Usability 1 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
timeFrame: 1 day
measure: Device Usability 2 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
timeFrame: 1 day
measure: Fluid retention as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
timeFrame: 1 day
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 2 weeks
measure: Time measured in minutes
timeFrame: 1 day
measure: Number of Device Deficiencies
timeFrame: 1 day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Sutter Health - 1101 Van Ness Ave
state: California
Study officials:
affiliation: Sutter Health
name: Andrew Nettt, MD
role: PRINCIPAL_INVESTIGATOR
References: