A Prospective Study Assessing ActivSight Imaging for Intraoperative Perfusion Evaluation in Left-Sided Colectomy (VISION)

A Single Arm, Prospective, Open Label, Multicenter Study Assessing Efficacy and Utility of the Visualization of Intraoperative Speckle Imaging for Real-Time Assessment Of PerfusioN in Left Sided Colectomy With ActivSight

The goal of this clinical trial is to evaluate and compare the clinical utility of Indocyanine Green (ICG) fluorescence angiography and Laser Speckle

Contrast Imaging (LSCI) in assessing intraoperative tissue perfusion at the anastomotic site during colorectal resection in [describe participant population/primary condition; could include any of the following: sex/gender, age groups, healthy volunteers]. The main question[s] it aims to answer [is/are]:

What is the clinical utility of Indocyanine Green (ICG) fluorescence angiography compared to Laser Speckle Contrast Imaging (LSCI) in assessing intraoperative tissue perfusion at the anastomotic site during colorectal resection?

Participants will undergo a laparoscopic/robotic (where an extracorporeal anastomosis formed)/open colectomy with ligation of the inferior mesenteric artery and a planned anastomosis of 5cm to 15 cm from the anal verge where both ICG and LSCI modalities will be applied to all subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: ActivSight™ Intraoperative Imaging System

Detailed Description

This is a single-arm, prospective, non-randomized, within-patient crossover study designed to evaluate the effectiveness of Laser Speckle Contrast Imaging (LSCI) using ActivSight™ as an advanced intraoperative visualization tool for assessing tissue perfusion in left-sided colectomies. The standard of care-Indocyanine Green (ICG) fluorescence angiography-will be used concurrently to compare perfusion assessment capabilities between the two imaging modalities. The study will also explore the potential of LSCI in reducing the incidence of anastomotic leak (AL) and related postoperative complications.

Participants will undergo left-sided colorectal resection (high or low) with planned anastomosis 5 - 15cm from the anal verge using a circular stapler. The procedure may be performed using either a laparoscopic, open or robotic approach with standard surgical equipment based on the surgeon's standard technique.

• High anterior resection is defined as resection and anastomosis above the peritoneal reflection.
• Low anterior resection refers to resection and anastomosis below the peritoneal reflection.

The specific operative technique, including the method of stapled will be at the discretion of the operating surgeon. The level of colonic transection, formation of an anastomosis, and any defunctioning stoma will be performed in accordance with the surgeon's standard clinical practice

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject is scheduled for laparoscopic/robotic (where an extracorporeal anastomosis formed)/open colectomy with ligation of the inferior mesenteric artery and a planned anastomosis of 5cm to 15 cm from the anal verge using a circular stapler only
• A negative pregnancy test for women of childbearing potential prior to surgery
• Participants who are able and willing to complete required study procedures
• Participants who are able and willing to provide a signed and dated ICF

Exclusion Criteria:

• Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes
• Subject who receives hand sewn anastomosis
• Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the study procedure
• Subject has a previous history of radiation therapy
• Subject that has Hinchey 3 and 4 diverticulitis
• Subject is a pregnant or lactating female

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: ICG & LSCI; Intervention is the Activsight Intraoperative Imaging System. Both imaging modalities, ICG and LSCI, will be utilized during surgery for all subjects.

Device: ActivSight™ Intraoperative Imaging System; ActivSight™ Intraoperative Imaging System which consists of an infrared-sensitive monochrome imaging sensor adapter and a customized light source with 1 or more coherent laser sources. In LSCI mode, proprietary algorithms detect perfusion using motion in real time, projecting a false color overlay on the standard white light laparoscopic image. This Food and Drug Administration-approved technology has the capacity for both ICG NIRF and LSCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White Light Imaging	Determine optimal proximal bowel transection site using white light imaging or naked eye, marking with clip, bovie, pen, etc.	during surgery
ICG Uptake	Determine the optimal proximal bowel transection site using at initial uptake of ICG prior to division of bowel and determine diffusion of ICG at 30 seconds, 60 seconds and 90 seconds after initial uptake.	during surgery
LSCI-based Perfusion	Determine the optimal proximal bowel transection site using LSCI-based perfusion imaging prior to division of bowel.	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Perfusion	Assess and compare tissue perfusion prior to anastomosis being completed (e.g. anvil has been placed) and post-anastomosis stages using LSCI and ICG.	during surgery
Diversion	Decision to divert or not to divert	during surgery
Surgical Decision Making	Impact on intraoperative surgical decision-making, including changes in transection site or operative plan.	during surgery
Anastomotic Leak Rate	Determine <30-day postoperative anastomotic leak (AL) rate, associated complications, morbidity, mortality and overall complication rates using the Clavien-Dindo classification system.	from surgery to end of follow up period/30 days post surgery

Collaborators and Investigators

• Sponsor: Activ Surgical

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: AS CRS 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes