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ICG for Gallbladder Disorders
N/A
Recruiting
Led By Peter Kim, MD, PhD
Research Sponsored by Activ Surgical
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 one month after each procedure
Awards & highlights
Study Summary
This trial will test if an AI model can assess a surgical procedure like a trained surgeon.
Who is the study for?
Adults over 18 needing elective gallbladder removal due to conditions like gallstones can join. They must understand the local language, be able to follow study procedures, and have normal organ function tests. Excluded are those with allergies to ICG dye, liver disease, coagulopathy, pregnant or breastfeeding women, and anyone unable to consent.Check my eligibility
What is being tested?
The trial is testing an AI model's ability to identify surgical structures and phases during laparoscopic cholecystectomy against traditional methods by trained surgeons. Surgeons will operate as usual while the AI analyzes video data without altering their view.See study design
What are the potential side effects?
Since this trial involves observation by AI without changing the surgery process itself, there are no additional side effects from the intervention being tested beyond standard risks associated with laparoscopic cholecystectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month after each procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month after each procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Precision and accuracy
Secondary outcome measures
Complication rate
Conversion rate to open procedure
Length of hospital stay
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Indocyanine green (ICG)Experimental Treatment1 Intervention
Patients in this arm will receive an intravenous injection of indocyanine green (ICG) 45 minutes prior to the start of surgery. This will be used to visualize the biliary anatomy using ActivSight, a device that is FDA 510(k)-cleared for this indication.
The surgeon will perform the procedure in their standard fashion using ActivSight.
ActivInsight artificial intelligence will be used to analyze the surgical video in real time to identify anatomic structures and phases of surgery.
Group II: Non-Indocyanine Green (Non-ICG)Active Control1 Intervention
The surgeon will perform the procedure in their standard fashion without the use of ICG.
ActivInsight artificial intelligence will be used to analyze the surgical video in real time to identify anatomic structures and phases of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ICG
2014
Completed Phase 1
~580
Find a Location
Who is running the clinical trial?
Activ SurgicalLead Sponsor
2 Previous Clinical Trials
137 Total Patients Enrolled
Peter Kim, MD, PhDPrincipal InvestigatorActiv Surgical
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within normal ranges.I don't have trouble breathing at rest and my oxygen level is above 94%.Your platelet count is at least 75,000 per microliter, and if it's lower, you may receive a transfusion.Your blood clotting tests are within the normal range.My kidney function is normal for my age.People who may need extra protection or care.I have a blood clotting disorder or liver disease.I am unable to give consent for myself.Your imaging tests like ultrasound, CT scan, or MRI show typical findings for your condition.Your hemoglobin level is higher than 9 grams per deciliter.I am under 18 years old.I had emergency gallbladder removal surgery.I do not have chronic kidney issues, drug allergies, or a history of severe allergic reactions, and I am not pregnant.You are allergic to indocyanine green (ICG).I am over 18 and scheduled for elective gallbladder removal surgery.I have had surgery before.I am diagnosed with gallbladder issues and scheduled for surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Indocyanine green (ICG)
- Group 2: Non-Indocyanine Green (Non-ICG)
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 opportunities for individuals to participate in this experiment presently?
"Based on the information found online, this particular medical trial is not taking applicants. This medical investigation was originally posted April 1st 2023 and last modified March 7th 2023. Participants can still look into other studies that are presently recruiting patients though; there are currently 68 different clinical trials searching for volunteers."
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