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LaparoGuard System for Laparoscopic Surgery
N/A
Waitlist Available
Led By Niv Sne, MD
Research Sponsored by Mariner Endosurgery
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 2 months
Awards & highlights
Study Summary
This trial tests a device that helps surgeons stay within a safe area during laparoscopic surgery, and alerting them if they leave it.
Who is the study for?
This trial is for patients undergoing common laparoscopic surgeries, such as appendectomy or hernia repairs. Participants must be able to read and understand English and give consent to use the LaparoGuard system during their procedure. Those unwilling to consent or who may need a traditional open surgery for safety reasons are excluded.Check my eligibility
What is being tested?
The trial is testing the LaparoGuard System, which helps surgeons by alerting them if surgical instruments leave a predefined safe area inside the patient's body during laparoscopic procedures. It aims to enhance safety in these minimally invasive surgeries.See study design
What are the potential side effects?
Since this trial focuses on the feasibility of using a new surgical tool rather than medication, it does not directly involve drug-related side effects. However, there could be potential risks associated with device malfunction or misuse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Procedural Success
Secondary outcome measures
Clinical utility reported by expert surgeons
Pre-operative LaparoGuard system setup time
Safe zone deviations
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LaparoGuard SystemExperimental Treatment1 Intervention
All patients receiving laparoscopic surgery, candidates for prolonged time under anesthesia, and are admitted for gynecological, urological or general surgery procedures who consent to use of the LaparoGuard System.
Find a Location
Who is running the clinical trial?
Mariner EndosurgeryLead Sponsor
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,933 Total Patients Enrolled
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)OTHER
3 Previous Clinical Trials
528 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and agree to use the LaparoGuard system in my surgery.I am having a routine laparoscopic surgery like gallbladder removal or hernia repair.My surgery was changed to an open procedure for safety.I have had or am scheduled for a simple diagnostic laparoscopy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new enrollees being accepted into this experiment?
"Official records on clinicaltrials.gov have indicated that this trial, which began accepting candidates in June of 2019 and was most recently updated in March of 2023, is not actively recruiting at present. Nonetheless, two corresponding medical studies are still seeking participants."
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