70 Participants Needed

ActivSight Imaging for Esophageal Surgery

Recruiting at 2 trial locations
PK
CM
Overseen ByChris McCulloh, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively.Primary Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. The investigators will compare the precision and accuracy among the naked eye inspection, ICG and LSCI in assessing the vascularity of the conduit.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Having provided signed consent
Ability to understand and follow study procedures
Normal PT, PTT and INR < 1.5 x ULN (including patients on prophylactic anticoagulation)
See 8 more

Exclusion Criteria

Patients currently in any investigational agents
I do not have chronic kidney issues, allergies to ICG or iodides, and am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

ActivSight™ is used intraoperatively to visualize tissue perfusion and blood flow during esophageal surgery

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with a focus on adverse events and clinical outcomes

28 days

What Are the Treatments Tested in This Trial?

Interventions

  • ActivSight
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ActivSight GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Activ Surgical

Lead Sponsor

Trials
4
Recruited
260+

West Penn Allegheny Health System

Collaborator

Trials
36
Recruited
6,000+

University of Pittsburgh Medical Center

Collaborator

Trials
78
Recruited
77,600+
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