An interventional study of EFFIDRAIN and Manual drainage system in Pleural Effusion and Ascites, sponsored by Changi General Hospital. Recruiting at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Changi General Hospital · Not applicable, Interventional, and Treatment
The goal of this Effidrain first-in-human medical device trial is to improve the outcomes of patients with pleural effusions and ascites.
The main aims are:
The secondary aims are related to explore the effects of Effidrain on health-related outcomes:
Participants will be randomized to control and intervention group. Control group will be receiving treatment using manual drainage system while intervention group will be using Effidrain machine.
Participants and Nurses from both control and intervention group will be asked to fill participant/nurses questionnaire form respectively.
The mission of the Effidrain first-in-human medical device trial is to improve the outcomes of patients with pleural effusions and ascites.
The primary aim of this first-in-man device pivotal study (n=120) is to demonstrate that the body fluid drain regulator can perform the function of pleural or ascites drainage, accurately and precisely.
The primary hypothesis is that the group of patients with device drainage intervention would be able to demonstrate actual fluid drainage not more than 110% of the physician-prescribed drainage volume and time.
The secondary aims are related to explore the effects of Effidrain on health-related outcomes:
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Changi General Hospital is the lead sponsor of 101 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours
Device: EFFIDRAIN · Device: Manual drainage system
Patient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours
Device: EFFIDRAIN · Device: Manual drainage system
. Effidrain is a progammable, light-weight, portable drain regulator that can control the rate and volume of body fluid being drained, while empowering the user with information on dynamic changes of pressure within the body cavity being drainged. It is able to adapt to existing drainage systems via a standard medical luer taper connector, and comes with a failsafe system to alert users of drainage irregularities.
drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.
demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely
A session completed by the medical device not exceeding 10% volume of the physican precribed drainage volume is considered a success and scored as completely meeting device efficacy criteria. A session completed by the medical device not exceeding 25% volume of the physican precribed drainage volume is considered a success and scored as partially meeting device efficacy criteria. A session completed by the medical device exceeding 25% volume of the physican precribed drainage volume is considered a failure and scored as not meeting device efficacy criteria.
Time frame: after 72 hours of usage per patient
Reduction in time that a subject requires a chest or abdominal drain in-situ
Mean difference between of physician-planned drainage volume and time required, vs actual drainage volume and time, in both intervention and control arms will be analysed using T-tests.
Time frame: Total of 4 hours for Pleural arm and 5 hours for Ascites arm
Reduction in time required for post-procedure monitoring by healthcare workers
Further analysis involve quantifying the effect of Effidrain on health-related outcomes such as: 1. Reduction in time that a subject requires a chest or abdominal drain in-situ 2. Reduction in time required for post-procedure monitoring by healthcare workers 3. Inpatient hospitalisation days The median times for the variables above would be compared between interventional and control groups using Mann Whitney U tests
Time frame: after 72 hours of usage per patient
Improvement in cost-effectiveness of care for each inpatient episode of pleural effusion or ascites that requires drainage.
To estimate the costs, the following cost and probabilities data will be extracted from the different databases, including the hospital's electronic database: 1. Number of patients requiring pleural and abdominal drainage in Changi General Hospital per year 2. Costs of developing the Effidrain from hospital perspective 3. Costs of maintaining the Effidrain from hospital perspective (including man-hours and actual expenditure incurred by the hospital) 4. Man-hours and unit cost of man-hours in conducting pleural and abdominal drainage using the Effidrain 5. Man-hours and unit cost of man-hours in conducting pleural and abdominal drainage using manual drainage 6. Length of stay of patients using the Effidrain and the manual drainage
Time frame: after 72 hours of usage per patient
Started Feb 2023 (actual). Primary completion is estimated for Sep 2025, 31 months after the start.
Of 61 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 31 months is close to that.
Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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