Esophagus CancerNCT05591053
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
A study testing ActivSight in people with Esophagus Cancer and Esophageal Cancer, run by Activ Surgical at 2 sites in United States.
Trial summary
ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophagus Cancer, Esophageal Cancer, Esophageal Neoplasms
- What is being tested?
- ActivSight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients age > 18 years old undergoing laparoscopic esophageal resection and reconstruction surgery; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
- Diagnosis:
- All patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection.
- Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
- Location of pathology or resected segment:
- Target lesions can be located in any fore-, mid- or hindgut segments requiring reconstruction and anastomoses.
Show all 14Show fewer
- Prior therapy:
- Patients with prior surgery are eligible for enrollment.
- Laboratory:
- Hemoglobin > 9 g/dL
- Platelet count ≥75,000/µL (may receive transfusions)
- Normal PT, PTT and INR < 1.5 x ULN (including patients on prophylactic anticoagulation)
- Renal function: Age-adjusted normal serum creatinine derived from Schwartz formula for estimating GFR by the CDC OR a creatinine clearance ≥60 mL/min/1.73 m2 for safe
- Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.
Who cannot join
- There is no exclusion criteria for ActivSightTM for esophageal surgery.
- Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, known allergy to iodides, breast-feeding or being of reproductive age with pregnancy possible and not ruled out, and pregnancy.
- Patients currently in any investigational agents.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15213
Julie Ward, RN, BSN, 412-647-8583, wardj@upmc.edu
Inderpal S Sarkaria, MD
- Not yet recruiting
West Penn Hospital / Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
Meredith Schwarz, RN, MSN
Blair A Jobe, MD
About this study
ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively.
Primary Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. The investigators will compare the precision and accuracy among the naked eye inspection, ICG and LSCI in assessing the vascularity of the conduit.
Read the detailed description
Design:
- This is a prospective interventional cross-over study where ActivSight™ will be used in sequence to the standard practice of visualizing perfusion status of the conduit using the naked eye visual inspection and ICG during esophageal resection.
- Feasibility will be determined by technically successful completion of intended visualization.
- Safety will be determined through clinical assessments and evaluation of any adverse event.
- Assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to ICG-based visualization and usability.
- Patient outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
- Target enrollment for the assessment of esophageal anastomoses is a total of seventy patients powered to detect ~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized sites in the gastric conduit. Since ActivSight™ can detect the difference of > 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators will recruit a total of 70 patients for the proposed study.
- Conditions
- Esophagus Cancer, Esophageal Cancer, Esophageal Neoplasms, Esophageal Diseases, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
- Being tested
- ActivSight
- Keywords
- laparoscopic, robot assisted surgery, gastrointestinal anastomoses, esophagectomy, esophageal surgery, thoracic surgery, alimentary surgery, perfusion, indocyanine green (ICG), laser speckle contrast imaging (LSCI), cancer, minimally invasive surgery (MIS)
- Medical subject headings
- Esophageal Neoplasms, Esophageal Diseases, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivSightDevice
Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy.
| Study group | Role | What they receive |
|---|---|---|
| ActivSight Group | Experimental | Patients undergoing esophagectomy with ActivSight (n=70) Receives: Device: ActivSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events in 28 days following use of ActivSight™
To determine safety of ActivSight™ in patients undergoing esophageal surgery, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSight™ will be deemed safe if no hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered.
Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test.
Measured: 28 days
Preparation time of ActivSight™.
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How easy was ActivSight to set up?
Measured: 1 day
Latency of display of ActivSight™.
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?
Measured: 1 day
Resolution and objectivity of display of ActivSight™.
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?
Measured: 1 day
Specificity of display of ActivSight™.
Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: "Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?"
Measured: 1 day
Usability of ActivSightTM by surgeon, as quantified by Likert scale.
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to use while operating."
Measured: 1 day
Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to set up for the procedure."
Measured: 1 day
User feedback on utility of relative perfusion unit display versus color heatmap
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree):
Measured: 1 day
Episodes of intraoperative decision change based on display
Yes/No if surgeons changed intraoperative planning/decisions based on ActivSight™, with additional details (what did they change and why) requested if yes.
Measured: 1 day
Usability of the device by surgeon and support personnel satisfaction;
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree):
Measured: 1 day
Secondary outcomes (2)
Ability of ActivSightTM to display perfusion.
ActivSightTM ability to display perfusion at a tissue level during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display tissue perfusion of the anatomy during anastomoses in comparison to ICG?"
Measured: 1 day
Ability of ActivSightTM to display blood vessels.
ActivSightTM ability to display blood vessels during gastrointestinal anastomoses is measured by the following Yes/No question for the surgeon: "Does ActivSightTM display vascularity of the anatomy during anastomoses in comparison to ICG?"
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Apr 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Target enrollment for the assessment of esophageal anastomoses is a total of 70 patients powered to detect \~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized site in the gastric conduit. Since ActivSight™ can detect the difference of \> 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p\<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators recruit a total of 70 patients for the proposed study.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Activ Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center, West Penn Allegheny Health System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591053
- Sponsor's protocol ID
- ACF0052020
- Status last verified
- Feb 2024
- First submitted
- 17 Oct 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
- ClinicalTrials.gov ID
- NCT05591053
- Acronym / sponsor ID
- ACF0052020
- Conditions
- Esophagus Cancer, Esophageal Cancer, Esophageal Neoplasms, Esophageal Diseases, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
- Keywords
- laparoscopic, robot assisted surgery, gastrointestinal anastomoses, esophagectomy, esophageal surgery, thoracic surgery, alimentary surgery, perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Activ SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Pittsburgh Medical Center, West Penn Allegheny Health System
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Oct 2022 (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.
ActivSight™ combines an innovative form factor and proprietary software to deliver precise, objective, real-time visualization of blood flow and tissue perfusion intraoperatively for laparoscope-based surgery. A small adaptor that fits between any existing laparoscope and camera systems and a separate light source placed along any current commercial system will deliver objective real-time tissue perfusion and blood flow information intraoperatively.
Primary Objective: To determine the feasibility of ActivSight™ in detecting and displaying tissue perfusion and blood flow in the conduit and foregut anastomoses in esophageal resection/reconstructive surgery. The investigators will compare the precision and accuracy among the naked eye inspection, ICG and LSCI in assessing the vascularity of the conduit.
Detailed description
Design:
- This is a prospective interventional cross-over study where ActivSight™ will be used in sequence to the standard practice of visualizing perfusion status of the conduit using the naked eye visual inspection and ICG during esophageal resection.
- Feasibility will be determined by technically successful completion of intended visualization.
- Safety will be determined through clinical assessments and evaluation of any adverse event.
- Assessment of preliminary efficacy will be performed through analysis of any intraoperative decisions made based on visual display as compared to standard endoscopic approach, or non-inferiority to ICG-based visualization and usability.
- Patient outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
- Target enrollment for the assessment of esophageal anastomoses is a total of seventy patients powered to detect ~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized sites in the gastric conduit. Since ActivSight™ can detect the difference of > 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators will recruit a total of 70 patients for the proposed study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Target enrollment for the assessment of esophageal anastomoses is a total of 70 patients powered to detect ~ 2-3 cm discordance between ICG and LSCI lines of demarcation between well vascularized and less vascularized site in the gastric conduit. Since ActivSight™ can detect the difference of > 2 cm between perfused versus less perfused in comparison to ICG with 80 % confidence at p<0.05 in a sample size of n = 21, the investigators estimate that the study will require an accrual of 63 patients. With potential unforeseen dropout and mortality, the investigators recruit a total of 70 patients for the proposed study.
| Arm | Type | Receives |
|---|---|---|
| ActivSight Group | Experimental | Device: ActivSightPatients undergoing esophagectomy with ActivSight (n=70) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All patients age > 18 years old undergoing laparoscopic esophageal resection and reconstruction surgery; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
- All patients with a clinical suspicion and diagnosis of benign or malignant, small or large bowel lesions requiring surgical resection.
- Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
- Target lesions can be located in any fore-, mid- or hindgut segments requiring reconstruction and anastomoses.
- Patients with prior surgery are eligible for enrollment.
Key exclusion criteria (3 listed)
- There is no exclusion criteria for ActivSightTM for esophageal surgery.
- Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, known allergy to iodides, breast-feeding or being of reproductive age with pregnancy possible and not ruled out, and pregnancy.
- Patients currently in any investigational agents.
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 |
|---|---|---|
| ActivSightUse of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy. | Device | ActivSight Group |
Primary outcome
Incidence of Adverse Events in 28 days following use of ActivSight™
Time frame: 28 days
To determine safety of ActivSight™ in patients undergoing esophageal surgery, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSight™ will be deemed safe if no hardware (adaptor or light source)-related major (serious) adverse event is encountered in the treated patients and if less than 2 hardware-related minor adverse events are encountered. Adverse events will be summarized descriptively and tabulations on the type, severity, and relationship to application will be performed and any changes of outcomes from baseline on follow up will be examined using the nonparametric Wilcoxon rank test.
Preparation time of ActivSight™.
Time frame: 1 day
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How easy was ActivSight to set up?
Latency of display of ActivSight™.
Time frame: 1 day
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How specifically did ActivSight display the intended field and the target tissue of interest?
Resolution and objectivity of display of ActivSight™.
Time frame: 1 day
Rate on a scale of 1-5 (1 = Difficult to use or Unsatisfied - 5 = no training required or very satisfied): How was the display quality of ActivSight on the intended field and target tissue of interest?
Specificity of display of ActivSight™.
Time frame: 1 day
Specificity of display will serve as an outcome for feasibility. Yes/No question for surgeon: "Does the perfusion information displayed by ActivSightTM reflect the expected pattern of blood flow interruption?"
Usability of ActivSightTM by surgeon, as quantified by Likert scale.
Time frame: 1 day
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to use while operating."
Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.
Time frame: 1 day
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree): "ActivSightTM was easy to set up for the procedure."
User feedback on utility of relative perfusion unit display versus color heatmap
Time frame: 1 day
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree):
Episodes of intraoperative decision change based on display
Time frame: 1 day
Yes/No if surgeons changed intraoperative planning/decisions based on ActivSight™, with additional details (what did they change and why) requested if yes.
Usability of the device by surgeon and support personnel satisfaction;
Time frame: 1 day
Likert scale ratings will serve as an outcome for feasibility. Scale 1-5 question (1=strongly disagree, 2=slightly disagree, 3=neutral, 4=slightly agree, 5=strongly agree):
2 secondary outcomes
Ability of ActivSightTM to display perfusion.
Time frame: 1 day
Ability of ActivSightTM to display blood vessels.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActivSight in people with Esophagus Cancer and Esophageal Cancer, run by Activ Surgical at 2 sites in United States.
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 14 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Kim, MD (2023202750, pkim@activsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events in 28 days following use of ActivSight™ (time frame: 28 days). The study lists 10 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 21 Feb 2024.