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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 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events in 28 days following use of ActivSightTM
Latency of display of ActivSightTM.
Preparation time of ActivSightTM.
+4 moreSecondary outcome measures
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
131 Previous Clinical Trials
98,892 Total Patients Enrolled
7 Trials studying Obesity
509 Patients Enrolled for Obesity
Ohio State UniversityOTHER
827 Previous Clinical Trials
502,684 Total Patients Enrolled
24 Trials studying Obesity
4,041 Patients Enrolled for Obesity
Activ SurgicalLead Sponsor
2 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research still actively seeking participants?
"The information hosted on clinicaltrials.gov indicates that this trial is no longer actively recruiting participants; the first posting was made November 17th 2020, and it has not been updated since April 29th 2021. Nevertheless, 884 different medical studies are still accepting patient enrolment at this time."
Answered by AI
Who else is applying?
What state do they live in?
New York
Texas
How old are they?
65+
What site did they apply to?
Kaleida Health, University of Buffalo
Memorial Hermann Sugar Land Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I received this email about trials for morbidly obese. I have health issues that could change if I could lose weight.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Yes does this study offer some kind of a device implai?
PatientReceived 2+ prior treatments
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