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
Verified date | August 2022 |
Source | WAE Medical |
Contact | IRENE LI |
Phone | 415-600-5848 |
Irene.Li[@]sutterhealth.org | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To validate the performance of the Poseidon System™ for fluid management during water-aided endoscopic procedures in the colon.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Sutter Health - 1101 Van Ness Ave | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
WAE Medical |
United States,
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 |
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