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

Starting soon · Not applicable

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07453797

Run by

Activ Surgical

People needed

150

Starts

2026-03-01

Expected to finish

2027-03-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.