Aqueduct Irrigation System Clinical Protocol: Medical Device Investigational Plan
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
A. Synopsis
- 1.This protocol comes to direct the experiment to be performed on the Aqueduct Automatic Continuous Irrigation system.
- 2.The Aquaduct System is aimed at reducing risks to the patient by decreasing the irrigation fluid pressure he may be exposed to, reducing the procedure time and therefore the anesthesia time, reducing the manual handling of the sterile bags and the risk of contamination and more.
- 3.In general since there is no new procedure suggested and the equipment does not actually come into contact with the human body in any direct way, there is no need to have a clinical study for the regulation purpose. The reason for performing this experiment is to demonstrate the new system and to find out the best way to operate it in order to improve the process and reduce risks.
- 4.This information will serve the development of most suitable automation solution for achieving the long desired continuous irrigation.
- 5.The experiment will be performed in the OR in MIS procedures, and will replace the standard gravitational manual method of performing the irrigation. The surgeons and the medical staff of the OR will be directed with the set up and operation of the system prior to using it. The experiment will be accompanied at all times with a knowledgeable representative of the research originator.
- 6.A maximum of 30 procedures will be analyzed during a period of approximately one month. The surgeons and the medical staff will report their impression of using the system during the procedures and will recommend the best settings achieved.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 14, 2015
July 1, 2015
3 months
July 9, 2015
July 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
continuous flow was maintained during the procedure
evaluation of the continuous nature of the treatment using the Aqueduct
3 Months
Ease of use
get qualitative assesment of the ease compared to standard procedure
3 months
Secondary Outcomes (1)
ideas for improvements
3 Months
Study Arms (2)
using Aqueduct
ACTIVE COMPARATORPatients passing procedures with Aqueduct
Not using Aqueduct
NO INTERVENTIONPatients passing the standard procedures
Interventions
Using Aqueduct in procedures to continuously supply the irrigation solutions
Eligibility Criteria
You may qualify if:
- All patients passing the specific procedures set on the Aqueduct
You may not qualify if:
- Non
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Flowmedlead
Related Publications (1)
i.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boaz Moskovitz, Prof.
Bnei-Zion
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2015
First Posted
July 14, 2015
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
July 14, 2015
Record last verified: 2015-07