ActivSight Imaging for Esophageal Surgery

Recruiting at 2 trial locations

Overseen By Chris McCulloh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Activ Surgical

Must not be taking: Investigational agents

Disqualifiers: Chronic renal dysfunction, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

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.

Eligibility Criteria

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)

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.

Treatment Details

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.

Participant Groups

Group I: ActivSight Group Experimental Treatment 1 Intervention

Patients undergoing esophagectomy with ActivSight (n=70)

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+