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

NCT05512026 | Unknown DMC FDA Device

• 1 other identifier: CLIN-0100
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colonic Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Number of Adverse Events

  2 weeks

• Time measured in minutes

  1 day

• Number of Device Deficiencies

  1 day

Study Arms (1)

Feasibility Assessment

EXPERIMENTAL

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

Interventions

Feasibility Assessment DEVICE

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

Feasibility Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• WAE Medical: lead

Study Sites (1)

Sutter Health - 1101 Van Ness Ave

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Andrew Nettt, MD

  Sutter Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IRENE LI

CONTACT

415-600-5848; Irene.Li@sutterhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will be de identified and assigned a designated number for inclusion in case report forms. Source documents will contain patient information and assigned study participant number.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: September 12, 2022
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)