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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
Summary
This trial is a prospective, single-center, feasibility study with two sequential cohorts.
Who is the study for?
Adults (18+) undergoing specific laparoscopic surgeries like gastric sleeve, bypass, or cholecystectomy can join this trial. They must be able to understand and consent to the study's procedures and have no severe allergies or conditions that would exclude them.
What is being tested?
The ActivSightTM system is being tested for its ability to provide real-time visualization of blood flow during surgery. It aims to improve outcomes in intestinal anastomoses and bariatric surgery by comparing it with traditional methods.
What are the potential side effects?
Since ActivSightTM is a visual aid used during surgery rather than a drug, it may not have direct side effects. However, risks could include potential complications from incorrect surgical decisions based on the device's imaging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Adverse Events in 28 days following use of ActivSightTM
Latency of display of ActivSightTM.
Preparation time of ActivSightTM.
+4 moreSecondary study objectives
Biliary tract structure
Ability of ActivSightTM to display blood vessels.
Ability of ActivSightTM to display perfusion.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ActivSight GroupExperimental Treatment1 Intervention
Patients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=52) Patients undergoing cholecystectomy with ActivSight (n=28)
Find a Location
Who is running the clinical trial?
University at BuffaloOTHER
132 Previous Clinical Trials
98,866 Total Patients Enrolled
7 Trials studying Obesity
471 Patients Enrolled for Obesity
Ohio State UniversityOTHER
859 Previous Clinical Trials
642,698 Total Patients Enrolled
24 Trials studying Obesity
3,974 Patients Enrolled for Obesity
Activ SurgicalLead Sponsor
3 Previous Clinical Trials
190 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis was confirmed with standard imaging tests like ultrasound, CT, or MRI.I am diagnosed with gallbladder issues and scheduled for surgery.My child is having surgery for a severe intestinal condition.My child is having surgery for severe intestinal inflammation.I am diagnosed with gallbladder issues and scheduled for surgery.My kidney function is within the normal range according to my age.I am eligible for ActivSightTM with no restrictions for my gastrointestinal surgery.I am 18 or older and will have laparoscopic or robot-assisted surgery to join parts of my intestine.I am 18 or older and scheduled for gallbladder removal surgery.My platelet count is at least 75,000, even if I've had transfusions.I am undergoing or have undergone a gastric sleeve or bypass surgery.I don't have trouble breathing at rest and my oxygen level is above 94% without assistance.My cancer involves areas needing surgical connection in my digestive tract.My surgery involves reconnecting parts of my digestive tract.I am over 18, understand the study, can follow instructions, and have signed the consent.I have had surgery before.My cancer involves areas needing surgical connection in my digestive tract.My doctor has used X-rays and contrast imaging to confirm my diagnosis.I am not pregnant, breastfeeding, allergic to iodides, and do not have liver disease, coagulopathy, or a history of bile duct injury.I am diagnosed with a bowel lesion that needs surgery.I don't have chronic kidney issues, drug allergies, or a history of severe allergic reactions, and I'm not pregnant.I am diagnosed with a bowel condition needing surgery.I have had surgery before.I am undergoing or have undergone a gastric sleeve or bypass surgery.I have had surgery before and can join the trial.My child is having surgery for severe intestinal inflammation.
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.
Obesity Patient Testimony for trial: Trial Name: NCT04633512 — N/A
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