Stream™ Platform for Detecting Anastomotic Leak

(CostAL Trial)

Not currently recruiting at 1 trial location

Overseen By Pablo Serrano, MD, MPH, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: FluidAI Medical

Disqualifiers: Pregnancy, Discharge < 8 hours, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the Stream™ Platform, to catch leaks early after gastrointestinal surgery, which can occur in surgeries involving the liver, intestines, or emergency care. The trial includes two groups: one uses the Stream™ Platform to monitor for leaks, and the other does not. Researchers aim to determine if this tool improves patient outcomes and reduces healthcare costs. Individuals who have undergone open or laparoscopic surgery and have abdominal or pelvic drains might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking advancement in surgical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Stream™ Platform is safe for detecting anastomotic leaks?

Research shows that the Stream™ Platform has been used in hospitals to detect leaks after stomach and intestine surgeries. Studies have demonstrated that this technology safely monitors patients by measuring the fluid around the surgery area. These studies have reported no major safety issues. The device measures pH and electrical conductivity, which do not interfere with the body, suggesting that the Stream™ Platform is generally well-tolerated.

In a previous study, the overall leak rate was low, at 1.4%, and no leaks occurred when the surgery plan was adjusted based on the platform's data. While this does not directly prove safety, it suggests the platform functions as intended without causing harm. For those considering joining this trial, this information can reassure about the platform's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stream™ Platform because it offers a novel approach to detecting anastomotic leaks after surgery. Unlike current methods that rely primarily on clinical observation and imaging, this platform continuously measures pH and electrical conductivity of abdominal drain fluid to generate a Risk Score. This score could provide surgeons with an early warning system, potentially allowing for quicker intervention and improved patient outcomes. By integrating real-time data with standard care, this technology aims to enhance the precision of postoperative management.

What evidence suggests that the Stream™ Platform is effective for detecting anastomotic leaks?

Research shows that the Stream™ Platform holds promise for early detection of leaks after gastrointestinal surgery. Earlier studies have demonstrated that this platform improves patient outcomes by continuously measuring pH and electrical conductivity in fluids from surgical drains. In this trial, the Intervention Group will use these measurements to calculate a Risk Score, alerting doctors to possible leaks early and potentially enhancing patient recovery while reducing healthcare costs. Meanwhile, the Control Group will have the platform attached for observation only, without generating a Risk Score. This method provides a non-invasive way to monitor patients post-surgery, which is a significant advantage. Overall, initial findings suggest that the Stream™ Platform could effectively improve surgical outcomes. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had open or laparoscopic gastrointestinal surgery with drainage and can follow the study's rules. It's not for pregnant individuals, those discharged within 8 hours post-surgery, anyone involved in planning this study, participants in conflicting studies, if more than 24 hours passed since their surgery, or if they're allergic to contrast medium.

Inclusion Criteria

Subjects must be willing to comply with trial requirements

Subject understands and has voluntarily signed and dated the informed consent form (ICF)

I have had surgery with drainage in my abdomen or pelvis.

Exclusion Criteria

Involvement in the planning and conduct of the clinical investigation

Subject is pregnant

Subject is allergic to contrast medium

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Stream™ Platform is attached to abdominal/pelvic drains for continuous pH and electrical conductivity measurements. Risk Scores are calculated and provided to surgeons in the intervention group.

12 months

Control

Stream™ Platform is attached to abdominal/pelvic drains for observation only, without impacting postoperative care in the control group.

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and re-admissions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stream™ Platform

Trial Overview The Stream™ Platform is being tested to see if it helps detect leaks early after gastrointestinal surgeries. Patients are divided into two groups: one using the Stream platform and another without it (control group). The goal is to compare patient outcomes and healthcare costs between these groups.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. The continuous pH and electrical conductivity measurements will be used to calculate a Risk Score that will be provided to surgeons. Surgeons will employ the Risk Score produced alongside the standard of care for guiding the postoperative care of patients.

Group II: Control Group Placebo Group 1 Intervention

Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid. However, Stream™ Platform will not generate a Risk Score and therefore, will not impact the postoperative care of patients. All procedures will be conducted as per the standard of care or institutional policies. Stream™ Platform will only be used for observation in the Control group.

Who Is Running the Clinical Trial?

FluidAI Medical

Lead Sponsor

Trials

5

Recruited

630+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Ontario Bioscience Innovation Organization

Collaborator

Trials

2

Recruited

410+

Citations

1. fluidai.md fluidai.md/clinical-evidence/

Evidence • FluidAI Medical Read about CostAL, a study that examines how early detection of anastomotic leaks with Stream™ Platform can improve outcomes and reduce healthcare costs. By ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06522061?locStr=Canada&country=Canada&cond=Anastomotic%20Leak%20in%20colorectal%20surgery&term=Home-Stream&rank=1

Evaluating the Effective and Safe Use of Stream™ Platform Data collected will be used to supplement Stream ™ Platform's existing clinical model for early prediction of leakage. Through study completion, an average of 6 ...

3. withpower.com withpower.com/trial/phase-3-anastomotic-leak-7-2023-23e6a

Stream™ Platform for Detecting Anastomotic Leak (CostAL Trial) The trial will track patient outcomes and healthcare costs in two groups: the intervention group, where the Stream platform is deployed, and the control group, ...

4. fluidai.md fluidai.md/colorectal/

Colorectal Read about CostAL, a study that examines how early detection of anastomotic leaks with Stream™ Platform can improve outcomes and reduce healthcare costs. By ...

5. scirp.org scirp.org/pdf/ss2024158_32301922.pdf

Surgeon Perspectives on Anastomotic Leaks and FluidAI's ... The platform's ability to non-invasively monitor drainage fluid and provide real-time data was seen as a substantial advancement, particularly ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06522061

Evaluating the Effective and Safe Use of Stream™ Platform Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use. Additionally, clinical testing will ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05994625

NCT05994625 | Economic Evaluation of Stream™ Platform The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platform for early detection of anastomotic leakage after ...

8. link.springer.com link.springer.com/article/10.1007/s00464-017-6001-3

Using outcomes data to justify instituting new technology The overall anastomotic leak rate in the study was 1.4% (N = 2) with no leaks in the 11 patients who had a change in surgical plan based on ...