Stream™ Platform for Detecting Anastomotic Leak

(CostAL Trial)

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

215 Participants Needed

Trial Summary

What is the purpose of this trial?

This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. 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 gastrointestinal surgery. 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, before the integration of the Stream™ Platform. The data collected from both groups will be compared to assess the impact of implementing the Stream™ Platform and early leak detection on overall patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and trauma/acute care patient populations.

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 data supports the effectiveness of the Stream™ Platform treatment for detecting anastomotic leaks?

The research highlights the importance of early detection of anastomotic leaks, with studies showing that monitoring C-reactive protein (CRP) levels can predict leaks effectively. This suggests that the Stream™ Platform, if it incorporates similar monitoring, could be effective in early leak detection. ^{1 2 3 4 5}

How does the Stream™ Platform treatment for detecting anastomotic leak differ from other treatments?

The Stream™ Platform is unique because it likely uses advanced microfluidic and capillary flow technologies to detect anastomotic leaks, which may offer more precise and timely detection compared to traditional methods. This approach could integrate features like lateral flow assays or microchannel capillary flow assays, which are known for their sensitivity and ability to perform complex reactions autonomously. ^{6 7 8 9 10}

Eligibility Criteria

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

I am 18 years old or older.

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

Exclusion Criteria

Subject is pregnant

Participation in another investigational drug or device study which would interfere with the endpoints of this study

I will be discharged within 8 hours after my surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors Affecting Hospital Mortality in Patients with Esophagogastric Anastomotic Leak: A Retrospective Study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Early complication detection after colorectal surgery (CONDOR): study protocol for a prospective clinical diagnostic study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The importance of presepsin value in detection of gastrointestinal anastomotic leak: a pilot study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

C-reactive protein trajectory to predict colorectal anastomotic leak: PREDICT Study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Diagnosis and Management of Intraoperative Colorectal Anastomotic Leaks: A Global Retrospective Patient Chart Review Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Capillary flow control in lateral flow assays via delaminating timers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Oil immersed lossless total analysis system for integrated RNA extraction and detection of SARS-CoV-2. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A portable, integrated analyzer for microfluidic - based molecular analysis. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Thermoplastic Electrode Arrays in Electrochemical Paper-Based Analytical Devices. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A new microchannel capillary flow assay (MCFA) platform with lyophilized chemiluminescence reagents for a smartphone-based POCT detecting malaria. [2021]