Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
1 other identifier
interventional
70
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedFebruary 21, 2024
February 1, 2024
1.8 years
October 17, 2022
February 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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.
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?
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?
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?
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?"
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."
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."
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):
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.
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):
1 day
Secondary Outcomes (2)
Ability of ActivSightTM to display perfusion.
1 day
Ability of ActivSightTM to display blood vessels.
1 day
Study Arms (1)
ActivSight Group
EXPERIMENTALPatients undergoing esophagectomy with ActivSight (n=70)
Interventions
Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Activ Surgicallead
- University of Pittsburgh Medical Centercollaborator
- West Penn Allegheny Health Systemcollaborator
Study Sites (2)
University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, 15213, United States
West Penn Hospital / Allegheny Health Network
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 24, 2022
Study Start
April 1, 2023
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
February 21, 2024
Record last verified: 2024-02