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To validate the performance of the Poseidon Systemâ„¢ for fluid management during water-aided endoscopic procedures in the colon.
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 Poseidonâ„¢ System is not yet FDA 510(k) cleared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feasibility Assessment | Device | To validate the performance of the Poseidon Systemâ„¢ for fluid management during water-aided endoscopic procedures in the colon. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time measured in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| IRENE LI | Contact | 415-600-5848 | Irene.Li@sutterhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Nettt, MD | Sutter Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Health - 1101 Van Ness Ave | San Francisco | California | 94109 | United States |
Not applicable to this trial. Trial and device validation will be used to commercially release product only.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2022 | Aug 22, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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.
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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.
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Procedure time measured in minutes from the point of scope insertion to the point of scope removal (scope-in / scope-out).
| 1 day |
| 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 |