Clinical Validation of Programmable Drain Fluid Regulator to Reduce Morbidity, Care Requirements, and Improve Outcomes

NCT05734729 | Unknown DMC

• 1 other identifier: EFFIDRAIN
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Pleural Effusion; Ascites

Keywords

Medical device; Pleural effusion; Ascites; Drainage; Novel

Outcome Measures

Primary Outcomes (1)

• 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.

  after 72 hours of usage per patient

Secondary Outcomes (3)

• Reduction in time that a subject requires a chest or abdominal drain in-situ

  Total of 4 hours for Pleural arm and 5 hours for Ascites arm

• Reduction in time required for post-procedure monitoring by healthcare workers

  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.

  after 72 hours of usage per patient

Study Arms (2)

Pleural Arm

EXPERIMENTAL

Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours

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

Device: EFFIDRAIN; Device: Manual drainage system

Interventions

EFFIDRAIN DEVICE

. 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.

Ascites arm; Pleural Arm

Manual drainage system DEVICE

drainage systems required manual control and are unautomated; consequent unintended rapid intravascular and extravascular fluid shifts may result in clinical instability.

Ascites arm; Pleural Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Pleural Effusion; Ascites

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica Quah Lishan

CONTACT

9679 7074; jessica.quah.l.s@singhealth.com.sg

CTRU Mainline

CONTACT

64267818; CTRU@cgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: February 27, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

SG (1)