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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 28 days
Awards & highlights
Study Summary
This trial uses a device that creates a visual representation of blood flow and tissue perfusion during laparoscopic surgery. It will compare accuracy of the device to naked eye inspection and other imaging techniques.
Who is the study for?
This trial is for adults over 18 who need laparoscopic esophageal surgery. They must be able to understand the study, have normal organ function, and not suffer from severe breathing issues. People with allergies to ICG or iodides, pregnant women, those on certain drugs, or with chronic kidney problems can't join.Check my eligibility
What is being tested?
The ActivSight™ system is being tested during esophageal surgeries to see if it helps surgeons better visualize blood flow and tissue health compared to traditional methods like naked eye inspection or other imaging techniques.See study design
What are the potential side effects?
Since ActivSight™ is a visualization tool used during surgery rather than a drug, it doesn't have typical side effects. However, there may be risks associated with its use in surgery that will be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Episodes of intraoperative decision change based on display
Incidence of Adverse Events in 28 days following use of ActivSight™
Latency of display of ActivSight™.
+7 moreSecondary outcome measures
Blood Vessel
Ability of ActivSightTM to display perfusion.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ActivSight GroupExperimental Treatment1 Intervention
Patients undergoing esophagectomy with ActivSight (n=70)
Find a Location
Who is running the clinical trial?
West Penn Allegheny Health SystemOTHER
35 Previous Clinical Trials
5,939 Total Patients Enrolled
Activ SurgicalLead Sponsor
2 Previous Clinical Trials
187 Total Patients Enrolled
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
76,180 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have trouble breathing at rest and my oxygen level is above 94% without assistance.I do not have chronic kidney issues, allergies to ICG or iodides, and am not pregnant or breastfeeding.I need surgery for a suspected bowel lesion.My platelet count is at least 75,000, even if I've had transfusions.My kidney function is within the normal range according to my age.I have had surgery before.My cancer involves areas needing surgical connection in my digestive tract.I am over 18 and will have surgery to remove part of my esophagus.
Research Study Groups:
This trial has the following groups:- Group 1: ActivSight Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there any current opportunities for participating in this research study?
"Per information available through clinicaltrials.gov, this research venture is not presently accepting new participants. Despite the fact that it commenced on November 1st 2022 and was updated as recently as 11th of November 2022, there are currently no recruitment slots open; however, 3475 other studies have vacancies for potential candidates at this time."
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