Back to resultsPerformance of the Poseidon System for Fluid Management During Water-aided Colonoscopy
Primary Purpose
Colonic Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feasibility Assessment
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Disease
Eligibility Criteria
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.
Sites / Locations
- Sutter Health - 1101 Van Ness Ave
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Feasibility Assessment
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
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
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.
Secondary Outcome Measures
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.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05512026
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 12, 2022 (Anticipated)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WAE Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
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.
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feasibility Assessment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Feasibility Assessment
Intervention Description
To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.
Primary Outcome Measure Information:
Title
Human Factors as assessed using the frequency of failure
Description
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).
Time Frame
1 day
Title
Colonoscope Control as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Description
User shall not adversely influence typical actuation of a scope during colonoscopy procedure as assessed using a 5-point Likert scale.
Time Frame
1 day
Title
Device Usability 1 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Description
User assessment of functional acceptability of Poseidon device ratchet location as assessed using a 5-point Likert scale.
Time Frame
1 day
Title
Device Usability 2 as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Description
User assessment of functional acceptability of Poseidon device intergluteal cleft fit as assessed using a 5-point Likert scale
Time Frame
1 day
Title
Fluid retention as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
Safety defined as the occurrence of all adverse events measured from the Index Procedure through the 2 Week Post Procedure Follow-up Visit.
Time Frame
2 weeks
Title
Time measured in minutes
Description
Procedure time measured in minutes from the point of scope insertion to the point of scope removal (scope-in / scope-out).
Time Frame
1 day
Title
Number of Device Deficiencies
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IRENE LI
Phone
415-600-5848
Email
Irene.Li@sutterhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Nettt, MD
Organizational Affiliation
Sutter Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Health - 1101 Van Ness Ave
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Nguyen
Email
Laura.Nguyen@sutterhealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not applicable to this trial. Trial and device validation will be used to commercially release product only.
Learn more about this trial
Performance of the Poseidon System for Fluid Management During Water-aided Colonoscopy
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