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: 1

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called ActivSight™ to help surgeons assess blood flow and tissue health during esophageal surgery. The researchers aim to determine if ActivSight™ provides more precise and accurate information than the naked eye and other current technologies. The trial seeks participants who require laparoscopic esophageal surgery for conditions like benign or cancerous bowel lesions. Candidates who have had prior surgery and meet specific health criteria may qualify for this study.

As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative surgical tools that could improve surgical outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on any investigational agents, you cannot participate in the trial.

What prior data suggests that ActivSight is safe for esophageal surgery?

Research shows that ActivSight™ is being carefully monitored for safety in esophageal surgery. In earlier studies, researchers closely monitored participants for any negative side effects during and after surgery. The main goal was to ensure the treatment's safety and effectiveness in providing real-time information about blood flow and tissue health. Although detailed results from these studies are not available, the use of this treatment in such procedures suggests it is considered safe enough for further research. This indicates that ActivSight™ is currently deemed safe for larger-scale testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ActivSight because it offers a new way to enhance visualization during esophageal surgeries. Traditional esophagectomy techniques rely on the surgeon's visual assessment, which can sometimes result in complications due to limited visibility. ActivSight uses advanced imaging technology to provide real-time, enhanced visualization of the surgical field, potentially improving precision and outcomes. This innovation could lead to fewer complications and faster recovery times for patients undergoing esophageal surgery.

What evidence suggests that ActivSight is effective for esophageal surgery?

Research shows that ActivSight™ can help detect and display blood flow and tissue perfusion during esophageal surgery. This new technology uses a small attachment and a separate light to integrate with existing surgical cameras. It provides surgeons with a real-time, detailed view to assess tissue health. Although human data remains limited, the technology aims to improve surgical outcomes by offering clear images of blood flow. This could lead to better recovery and fewer complications in esophageal surgeries. Early findings suggest that this technology might reveal important details not visible to the naked eye. Participants in this trial will undergo esophagectomy using ActivSight to evaluate its effectiveness in enhancing surgical outcomes. ^{1 3 6 7 8}

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)

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?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05591053

Utility and Usability of ActivSight™ Laser Speckle Imaging ... Primary Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut ...

2. withpower.com withpower.com/trial/phase-esophagus-scc-10-2022-ca63b

ActivSight Imaging for Esophageal Surgery 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022522324010365

Textbook outcome after robotic and laparoscopic Ivor ... The achievement of textbook outcomes improves overall survival in patients after robotic-assisted minimally invasive esophagectomy for esophageal cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9474270/

Long-term Outcomes Following Esophagectomy in Older ... Patterns of overall and disease-free survival after esophagectomy for esophageal cancer in older adults have not been carefully studied.

5. mdpi.com mdpi.com/2072-6694/16/20/3538

Caseload per Year in Robotic-Assisted Minimally Invasive ... This review will explore how the caseload per year impacts the quality of patient care and surgical training, especially regarding robotic-assisted minimally ...

6. trialx.com trialx.com/clinical-trials/listings/273516/utility-and-usability-of-activsighttm-laser-speckle-imaging-in-visualization-of-tissue-perfusion-and-blood-flow-during-esophageal-surgery-in-humans/?&radius=50

Utility and Usability of ActivSight™ Laser Speckle Imaging ... This is a prospective interventional cross-over study where ActivSight™ will be used in sequence to the standard practice of visualizing ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666273625003729

Safety, efficacy, and patient satisfaction following ... ... data on outcomes after esophagectomy in this population. We sought to characterize the safety and efficacy of esophagectomy for esophageal ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11094488/

Totally minimally invasive laparoscopic robot-assisted Ivor ... Rate of postoperative pneumonia, 30- and 90-day mortality were reduced after 100 cases, although not statistically significant for mortality due ...