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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Singapore
Changi General Hospital
RECRUITING
Singapore
Contact Information
Primary
Jessica Quah Lishan
jessica.quah.l.s@singhealth.com.sg
9679 7074
Backup
CTRU Mainline
CTRU@cgh.com.sg
64267818
Time Frame
Start Date: 2023-02-27
Estimated Completion Date: 2025-09
Participants
Target number of participants: 120
Treatments
Experimental: Pleural Arm
Patient's maximum volume is 1 litre per hour, not to exceed total 4 litres over 4 hours
Experimental: Ascites arm
Patient's maximum volume is 3 litre per hour, not to exceed total 15 litres over 5 hours
Related Therapeutic Areas
Sponsors
Leads: Changi General Hospital

This content was sourced from clinicaltrials.gov

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