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NCT07453797Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 6 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
9 Jan 2026
Start date
Mar 2026
Primary completion date
Feb 2027
Lead sponsor
Activ Surgical
NCT number
NCT07453797

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From Mar 2026 to the primary completion date, Feb 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes
  • Subject has a previous history of radiation therapy

Other illness

  • 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

Other

  • Subject who receives hand sewn anastomosis
  • Subject that has Hinchey 3 and 4 diverticulitis
  • Subject is a pregnant or lactating female

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.