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

Pleural Effusion Clinical Trial

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

Status Recruiting

Clinical 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 ascites drainage, accurately and precisely.

• The secondary aims are related to explore the effects of Effidrain on health-related outcomes:

1. The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.

2. 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.

Clinical Trial 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:

1. The investigators hypothesize that Effidrain can reduce the time that the subject requires a pleural or abdominal drain in-situ, compared to conventional care.

2. 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. ;

Related Conditions & MeSH terms

• Ascites
• Pleural Effusion

• NCT number: NCT05734729
• Study type: Interventional
• Source: Changi General Hospital
• Contact: Jessica Quah Lishan
• Phone: 9679 7074
• Email: jessica.quah.l.s@singhealth.com.sg
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Completion date: September 2025