ActivSight for Colorectal Cancer

Recruiting 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

67 Participants Needed

Trial Summary

What is the purpose of this trial?

ActivSightTM 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 safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery. Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

Eligibility Criteria

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

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

Patients currently in any investigational agents

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

Timeline

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

Treatment Details

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.

Participant Groups

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+