ActivSight for Colorectal Cancer

Enrolling by invitation at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called ActivSight™, which aims to enhance surgeons' ability to see blood flow and tissue health during surgeries like colorectal and bariatric (weight-loss) procedures. The goal is to confirm the tool's safety and effectiveness in displaying real-time blood flow to tissues. The trial will also compare ActivSight™ with a standard dye used in surgeries to evaluate its ability to show blood vessels and other structures. Suitable candidates include those requiring surgery for bowel problems or gallbladder issues. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative surgical technology.

Do I need to stop my current medications for the trial?

The trial information 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 ActivSightTM is safe for use in surgery?

Research shows that ActivSight is generally safe for use in surgeries. One study found it safe and easy to use for displaying blood flow and tissue perfusion during operations. ActivSight integrates with existing surgical tools and has been tested to meet safety standards.

The system is FDA-cleared, indicating it has been reviewed and approved for specific medical uses. This clearance reassures its safety in humans.

Overall, studies indicate that ActivSight is well-tolerated, with no major safety concerns reported. It aids surgeons by providing clearer views of blood flow and tissues during procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

ActivSight is unique because it brings advanced imaging technology into surgeries for colorectal cancer. While standard treatments focus mainly on removing tumors, ActivSight enhances the surgeon's ability to visualize blood flow and tissue perfusion in real-time during operations. This improved visualization can help reduce complications and improve surgical outcomes by ensuring that tissues are properly connected and have adequate blood supply. Researchers are excited about ActivSight because it promises to make surgeries safer and more effective by offering insights that are not possible with current standard techniques.

What evidence suggests that ActivSight is effective for colorectal cancer surgery?

Research has shown that ActivSight, used by participants in this trial, can enhance surgery outcomes by improving the view of blood flow during operations. Studies suggest that this device offers real-time information, crucial during colorectal surgeries. ActivSight’s technology enables surgeons to assess blood flow through tissues, aiding in better decision-making. Findings from colorectal studies are promising, indicating that ActivSight may surpass traditional methods in effectiveness. Overall, the evidence supports its potential to increase surgical accuracy and safety. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

Adults (18+) undergoing specific laparoscopic surgeries like gastric sleeve, bypass, or cholecystectomy can join this trial. They must be able to understand and consent to the study's procedures and have no severe allergies or conditions that would exclude them.

Inclusion Criteria

My child is having surgery for a severe intestinal condition.

I am diagnosed with gallbladder issues and scheduled for surgery.

My kidney function is within the normal range according to my age.

Exclusion Criteria

Patients currently in any investigational agents

I am eligible for ActivSightTM with no restrictions for my gastrointestinal surgery.

I am not pregnant, breastfeeding, allergic to iodides, and do not have liver disease, coagulopathy, or a history of bile duct injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intestinal anastomoses or cholecystectomy using ActivSightTM to evaluate safety and feasibility

1 day

1 visit (in-person)

Follow-up

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

28 days

What Are the Treatments Tested in This Trial?

Interventions

• ActivSightTM

Trial Overview The ActivSightTM system is being tested for its ability to provide real-time visualization of blood flow during surgery. It aims to improve outcomes in intestinal anastomoses and bariatric surgery by comparing it with traditional methods.

How Is the Trial Designed?

Group I: ActivSight Group Experimental Treatment 1 Intervention

Patients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=52) Patients undergoing cholecystectomy with ActivSight (n=28)

Who Is Running the Clinical Trial?

Activ Surgical

Lead Sponsor

Trials

4

Recruited

260+

University at Buffalo

Collaborator

Trials

139

Recruited

105,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

University of Buffalo, Buffalo General Hospital

Collaborator

Trials

1

Recruited

70+

Citations

1. activsurgical.com activsurgical.com/news/activ-surgical-presented-findings-from-colorectal-study-using-its-activsight-intelligent-light-at-the-ascrs-annual-scientific-meeting

Activ Surgical Presented Findings from Colorectal Study ... ActivSight is an imaging module that provides enhanced visualization and real-time, on-demand surgical insights in the operating room, all in a ...

2. wexnermedical.osu.edu wexnermedical.osu.edu/departments/innovations/gastroenterology/blood-flow-device

Enhanced surgical visualization device that assesses ... Enhanced surgical visualization device that assesses blood flow shows promise for improving colorectal surgery outcomes.

3. surgicalroboticstechnology.com surgicalroboticstechnology.com/news/activ-surgical-announces-findings-from-colorectal-study-using-its-activsight-intelligent-light/

Activ Surgical Announces Findings from Colorectal Study ... Activ Surgical presented findings from Colorectal Study Using its ActivSight™ Intelligent Light at the ASCRS Annual Scientific Meeting.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06535555?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Activ%20Surgical%22))&rank=1

Safety and Feasibility of ActivSight(tm) in the Identification ... The main Objective of this study is to determine the safety and feasibility of a prototype ActivSightTM in identifying the ureter in real-time during ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05591053

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 perfusion status of the ...

6. activsurgical.com activsurgical.com/news/activ-surgical-announces-completion-of-first-ai-enabled-case-using-its-activsightintelligent-light

Activ Surgical Announces Completion of First AI-Enabled ... Activ Surgical is transforming the operating room today through its 501(k)-cleared ActivSight that seamlessly upgrades existing operating room ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K203550.pdf

K203550.pdf - accessdata.fda.gov Safety and performance of the ActivSight Intraoperative Imaging System has been evaluated and verified in accordance with design specifications ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1072751521005846

First-In-Human (FIH) Safety, Feasibility, and Usability Trial ... In this FIH trial, real-time detection/display of tissue perfusion and blood flow using ActivSight is safe, easy-to-use as measured by human factor testing, and ...