Colorectal CancerVISIONNCT07453797
A Prospective Study Assessing ActivSight Imaging for Intraoperative Perfusion Evaluation in Left-Sided Colectomy
A study testing ActivSight™ Intraoperative Imaging System in people with Colorectal Cancer, run by Activ Surgical.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ActivSight™ Intraoperative Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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]:
Read more
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.
Read the 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
- Conditions
- Colorectal Cancer
- Being tested
- ActivSight™ Intraoperative Imaging System
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivSight™ Intraoperative Imaging SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ICG & LSCI | Other | Intervention is the Activsight Intraoperative Imaging System. Both imaging modalities, ICG and LSCI, will be utilized during surgery for all subjects. Receives: Device: ActivSight™ Intraoperative Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Light Imaging
Determine optimal proximal bowel transection site using white light imaging or naked eye, marking with clip, bovie, pen, etc.
Measured: 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.
Measured: during surgery
LSCI-based Perfusion
Determine the optimal proximal bowel transection site using LSCI-based perfusion imaging prior to division of bowel.
Measured: during surgery
Secondary outcomes (4)
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.
Measured: during surgery
Diversion
Decision to divert or not to divert
Measured: during surgery
Surgical Decision Making
Impact on intraoperative surgical decision-making, including changes in transection site or operative plan.
Measured: 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.
Measured: from surgery to end of follow up period/30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Activ Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453797
- Sponsor's protocol ID
- AS CRS 01
- Acronym
- VISION
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07453797
- Acronym / sponsor ID
- VISION / AS CRS 01
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Activ SurgicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG & LSCI | Other | Device: ActivSight™ Intraoperative Imaging SystemIntervention is the Activsight Intraoperative Imaging System. Both imaging modalities, ICG and LSCI, will be utilized during surgery for all subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivSight™ Intraoperative Imaging SystemActivSight™ 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. | Device | ICG & LSCI |
Primary outcome
White Light Imaging
Time frame: during surgery
Determine optimal proximal bowel transection site using white light imaging or naked eye, marking with clip, bovie, pen, etc.
ICG Uptake
Time frame: during surgery
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.
LSCI-based Perfusion
Time frame: during surgery
Determine the optimal proximal bowel transection site using LSCI-based perfusion imaging prior to division of bowel.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ActivSight™ Intraoperative Imaging System in people with Colorectal Cancer, run by Activ Surgical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White Light Imaging (time frame: during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.