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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Water Exchange Colonoscopy With Artificial Intelligence-assisted Detection

NCT06173258

Colon Adenoma Colonoscopy Colon Polyp

COMPLETED NA

Microbiological and Organizational Impact of the Use of Bacteriologically Controlled Water in COLOscopy

NCT06688955

Colonoscopy

RECRUITING NA

RCT of Air Insufflation Versus Water Infusion Colonoscopy by Supervised Trainees

NCT00841282

Colorectal Cancer

COMPLETED NA

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

NCT02481219

Colorectal Cancer Screening

COMPLETED NA

Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy

NCT04684082

Colonic Irrigation

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Feasibility Assessment

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.

Group Type EXPERIMENTAL

Feasibility Assessment

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Feasibility Assessment

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No