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

Official title

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

Overview

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.

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

Interventions

• 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.

Primary outcome measures

• White Light Imaging [Time frame: during surgery]
• ICG Uptake [Time frame: during surgery]
• LSCI-based Perfusion [Time frame: during surgery]

Secondary outcome measures (4)

• Tissue Perfusion [Time frame: during surgery]
• Diversion [Time frame: during surgery]
• Surgical Decision Making [Time frame: during surgery]
• Anastomotic Leak Rate [Time frame: from surgery to end of follow up period/30 days post surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07453797 · AS CRS 01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗