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

NCT07453797 | Not Yet Recruiting FDA Device

• 1 other identifier: AS CRS 01
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Tissue Perfusion

  during surgery

• Diversion

  during surgery

• Surgical Decision Making

  during surgery

• Anastomotic Leak Rate

  from surgery to end of follow up period/30 days post surgery

Study Arms (1)

ICG & LSCI

OTHER

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

Interventions

ActivSight™ Intraoperative Imaging System DEVICE

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.

ICG & LSCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Activ Surgical: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-02