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Stream™ Platform for Detecting Anastomotic Leak (CostAL Trial)
Phase 3
Recruiting
Research Sponsored by FluidAI Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
CostAL Trial Summary
This trial studies the effects of using a new tech platform to detect early anastomotic leakage after surgery, to assess patient outcomes and healthcare costs. Two groups will be compared to see the impact of early detection.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves an economic evaluation of a monitoring platform rather than a drug or invasive procedure, direct side effects from interventions may not be applicable. However, there could be risks associated with incorrect readings leading to delayed treatment.
CostAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Does Stream™ Platform integrate well with the existing clinical workflow (1)?
Does Stream™ Platform integrate well with the existing clinical workflow (2)?
Does Stream™ Platform integrate well with the existing clinical workflow (3)?
+3 moreSecondary outcome measures
Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (1)?
Does Stream™ Platform allow for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to clinical judgment/laboratory assessment (2)?
Does Stream™ Platform reduce adverse events that are associated with anastomotic leak patients in colorectal, HPB, and trauma and acute care surgeries?
+2 moreCostAL Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment1 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 GroupPlacebo Group1 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.
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Who is running the clinical trial?
FluidAI MedicalLead Sponsor
2 Previous Clinical Trials
335 Total Patients Enrolled
2 Trials studying Anastomotic Leak
335 Patients Enrolled for Anastomotic Leak
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,786 Total Patients Enrolled
1 Trials studying Anastomotic Leak
120 Patients Enrolled for Anastomotic Leak
Ontario Bioscience Innovation OrganizationUNKNOWN
1 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will be discharged within 8 hours after my surgery.It has been at least 24 months since my last surgery.I am 18 years old or older.I have had surgery with drainage in my abdomen or pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Intervention Group been given authorization from the FDA?
"Based on the available evidence, we have rated Intervention Group's safety at a 3 out of 3. This is due to its Phase 3 status which implies efficacy and multiple rounds of proven security."
Answered by AI
Are there still vacancies accessible to willing participants in this research project?
"As per clinicaltrials.gov, the trial that was initially made public on August 1st 2023 is not presently searching for participants. Despite this, there are 15 other studies actively enrolling patients at present."
Answered by AI
What is the main goal of this clinical trial?
"This research trial, which is expected to span around one year, will measure its primary outcome of how Stream™ Platform integrates with the existing clinical workflow (2). Secondary objectives include assessing whether this technology allows for earlier postoperative anastomotic leak detection in colorectal, HPB, and trauma and acute care surgeries compared to traditional methods (2), reducing the need for non-conservative management or re-admission due to anastomotic leaks in those same types of surgery (1) as well as quantifying any reduction in emergency readmissions within 30 days after discharge caused by such leakage before and after implementation of Stream™"
Answered by AI
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