Pleural EffusionNCT05734729
Clinical Validation of Programmable Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes
A study testing EFFIDRAIN and Manual drainage system in people with Pleural Effusion and Ascites, run by Changi General Hospital at 1 site in Singapore.
Trial summary
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 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pleural Effusion, Ascites
- What is being tested?
- EFFIDRAIN and Manual drainage system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Feb 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pleural effusion or ascites as the primary indication for chest or abdominal drain insertion
- Expected ascites drainage volume more than 1 Litre or at least moderate sized pleural effusion (occupying more than one-third hemi-thorax)
- uncomplicated chest or abdominal drain insertion
- Adults aged 21 years, able to provide (or surrogate able to provide) consent.
Who cannot join
- Vulnerable persons, including but not limited to, pregnant women and prisoners
- Hemodynamic instability, defined by heart rate more than 120 beats per minutes and blood pressure less than systolic 90mmHg
- Haemothorax or Haemoperitoneum
- pneumothorax or pneumoperitoneum
- chest or abdominal drain insertion => 48 hours with more than estimated 50% of total body cavity fluid drained
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore
CTRU, 64267818
About this study
Official title: Clinical Validation of Programmable Chest and Abdominal Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes: First-In-Human Medical Device Study
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:
Read more
- 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 secondary aims are related to explore the effects of Effidrain on health-related outcomes:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied
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.
Read the detailed description
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:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied.
- Conditions
- Pleural Effusion, Ascites
- Being tested
- EFFIDRAIN, Manual drainage system
- Keywords
- Medical device, Pleural effusion, Ascites, Drainage, Novel
- Medical subject headings
- Pleural Effusion, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFFIDRAINDevice
. 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.
Manual drainage systemDevice
drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.
| Study group | Role | What they receive |
|---|---|---|
| Pleural Arm | Experimental | Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours Receives: Device: EFFIDRAIN; Device: Manual drainage system |
| Ascites arm | Experimental | Patient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours Receives: Device: EFFIDRAIN; Device: Manual drainage system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 72 hours of usage per patient
Secondary outcomes (3)
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.
Measured: 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:
- Reduction in time that a subject requires a chest or abdominal drain in-situ
- Reduction in time required for post-procedure monitoring by healthcare workers
- Inpatient hospitalisation days The median times for the variables above would be compared between interventional and control groups using Mann Whitney U tests
Measured: 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:
- Number of patients requiring pleural and abdominal drainage in Changi General Hospital per year
- Costs of developing the Effidrain from hospital perspective
- Costs of maintaining the Effidrain from hospital perspective (including man-hours and actual expenditure incurred by the hospital)
- Man-hours and unit cost of man-hours in conducting pleural and abdominal drainage using the Effidrain
- Man-hours and unit cost of man-hours in conducting pleural and abdominal drainage using manual drainage
- Length of stay of patients using the Effidrain and the manual drainage
Measured: after 72 hours of usage per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start27 Feb 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Quah Li Shan, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734729
- Sponsor's protocol ID
- EFFIDRAIN
- Status last verified
- Jan 2024
- First submitted
- 9 Feb 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Programmable Chest and Abdominal Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes: First-In-Human Medical Device Study
- ClinicalTrials.gov ID
- NCT05734729
- Acronym / sponsor ID
- EFFIDRAIN
- Conditions
- Pleural Effusion, Ascites
- Keywords
- Medical device, Pleural effusion, Ascites, Drainage, Novel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 secondary aims are related to explore the effects of Effidrain on health-related outcomes:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied
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.
Detailed description
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:
- The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.
- The investigators hypothesize that the time required for healthcare workers to perform post-procedure monitoring for subjects that require pleural or abdominal drainage using Effidrain, would be reduced compared to conventional care. The effect of technology on physician and nursing hours required for drain care, and cost-effectiveness of the intervention will be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleural Arm | Experimental | Device: EFFIDRAIN, Device: Manual drainage systemPatient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours |
| Ascites arm | Experimental | Device: EFFIDRAIN, Device: Manual drainage systemPatient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pleural effusion or ascites as the primary indication for chest or abdominal drain insertion
- Expected ascites drainage volume more than 1 Litre or at least moderate sized pleural effusion (occupying more than one-third hemi-thorax)
- uncomplicated chest or abdominal drain insertion
- Adults aged 21 years, able to provide (or surrogate able to provide) consent.
Key exclusion criteria (5 listed)
- Vulnerable persons, including but not limited to, pregnant women and prisoners
- Hemodynamic instability, defined by heart rate more than 120 beats per minutes and blood pressure less than systolic 90mmHg
- Haemothorax or Haemoperitoneum
- pneumothorax or pneumoperitoneum
- chest or abdominal drain insertion => 48 hours with more than estimated 50% of total body cavity fluid drained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EFFIDRAIN. 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. | Device | Ascites arm, Pleural Arm |
| Manual drainage systemdrainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability. | Device | Ascites arm, Pleural Arm |
Primary outcome
demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely
Time frame: after 72 hours of usage per patient
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.
3 secondary outcomes
Reduction in time that a subject requires a chest or abdominal drain in-situ
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
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.
Time frame: after 72 hours of usage per patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFFIDRAIN and Manual drainage system in people with Pleural Effusion and Ascites, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Quah Lishan (9679 7074 ext. 6620, jessica.quah.l.s@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demonstrate that the Effidrain can perform the function of pleural and ascites drainage in human subjects accurately and precisely (time frame: after 72 hours of usage per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.