Feasibility Assessment for Colonic Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sutter Health - 1101 Van Ness Ave, San Francisco, CA
Colonic Diseases
Feasibility Assessment - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

14 Primary · 6 Secondary · Reporting Duration: 2 weeks

1 day
Colonoscope Control
Colonoscope Control as assessed using a 5-point Likert scale
Colonoscope Control as assessed using a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Device Deficiencies
Device Usability 1
Device Usability 1 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).
Device Usability 2
Device Usability 2 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).
Fluid retention
Fluid retention 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).
Human Factors
Human Factors as assessed using the frequency of failure
Number of Device Deficiencies
Time
Time measured in minutes
2 weeks
Adverse Events
Number of Adverse Events

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Feasibility Assessment
1 of 1
Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Feasibility Assessment · No Placebo Group · N/A

Feasibility Assessment
Device
Experimental Group · 1 Intervention: Feasibility Assessment · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
Closest Location: Sutter Health - 1101 Van Ness Ave · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Colonic Diseases
0 CompletedClinical Trials

Who is running the clinical trial?

WAE MedicalLead Sponsor
Andrew Nettt, MDPrincipal InvestigatorSutter Health

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years of age or greater.
You have an indication to undergo water-aided colonoscopy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.