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ActivSight Imaging for Esophageal Surgery

N/A
Recruiting
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 28 days
Awards & highlights
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
Blood Vessel
Ability of ActivSightTM to display perfusion.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3 Previous Clinical Trials
187 Total Patients Enrolled
University of Pittsburgh Medical CenterOTHER
72 Previous Clinical Trials
76,794 Total Patients Enrolled

Media Library

ActivSight Group Clinical Trial Eligibility Overview. Trial Name: NCT05591053 — N/A
Esophageal Carcinoma Research Study Groups: ActivSight Group
Esophageal Carcinoma Clinical Trial 2023: ActivSight Group Highlights & Side Effects. Trial Name: NCT05591053 — N/A
ActivSight Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05591053 — N/A
~3 spots leftby Jan 2025
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