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Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans

Primary Purpose

Esophagus Cancer, Esophageal Cancer, Esophageal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ActivSight
Sponsored by
Activ Surgical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophagus Cancer focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

  • 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.

Sites / Locations

  • University of Pittsburgh Medical Center - Dept of Cardiothoracic SurgeryRecruiting
  • West Penn Hospital / Allegheny Health Network

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ActivSight Group

Arm Description

Patients undergoing esophagectomy with ActivSight (n=70)

Outcomes

Primary Outcome Measures

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.
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?
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?
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?
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?"
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."
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."
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):
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.
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):

Secondary Outcome Measures

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?"
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?"

Full Information

First Posted
October 17, 2022
Last Updated
July 18, 2023
Sponsor
Activ Surgical
Collaborators
University of Pittsburgh Medical Center, West Penn Allegheny Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05591053
Brief Title
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
Official Title
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Activ Surgical
Collaborators
University of Pittsburgh Medical Center, West Penn Allegheny Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus Cancer, Esophageal Cancer, Esophageal Neoplasms, Esophageal Diseases, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Esophagus SCC, Esophagus Tumor, Esophagus Adenocarcinoma, Esophagus Neoplasm
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)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ActivSight Group
Arm Type
Experimental
Arm Description
Patients undergoing esophagectomy with ActivSight (n=70)
Intervention Type
Device
Intervention Name(s)
ActivSight
Intervention Description
Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events in 28 days following use of ActivSight™
Description
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.
Time Frame
28 days
Title
Preparation time of ActivSight™.
Description
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?
Time Frame
1 day
Title
Latency of display of ActivSight™.
Description
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?
Time Frame
1 day
Title
Resolution and objectivity of display of ActivSight™.
Description
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?
Time Frame
1 day
Title
Specificity of display of ActivSight™.
Description
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?"
Time Frame
1 day
Title
Usability of ActivSightTM by surgeon, as quantified by Likert scale.
Description
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."
Time Frame
1 day
Title
Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.
Description
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."
Time Frame
1 day
Title
User feedback on utility of relative perfusion unit display versus color heatmap
Description
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):
Time Frame
1 day
Title
Episodes of intraoperative decision change based on display
Description
Yes/No if surgeons changed intraoperative planning/decisions based on ActivSight™, with additional details (what did they change and why) requested if yes.
Time Frame
1 day
Title
Usability of the device by surgeon and support personnel satisfaction;
Description
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):
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Ability of ActivSightTM to display perfusion.
Description
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?"
Time Frame
1 day
Title
Ability of ActivSightTM to display blood vessels.
Description
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?"
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA 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. EXCLUSION CRITERIA 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Kim, MD
Phone
2023202750
Email
pkim@activsurgical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chris McCulloh, MD
Phone
617-333-8162
Email
cmcculloh@activsurgical.com
Facility Information:
Facility Name
University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Ward, RN, BSN
Phone
412-647-8583
Email
wardj@upmc.edu
First Name & Middle Initial & Last Name & Degree
Inderpal S Sarkaria, MD
First Name & Middle Initial & Last Name & Degree
James D Luketich, MD
Facility Name
West Penn Hospital / Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meredith Schwarz, RN, MSN
First Name & Middle Initial & Last Name & Degree
Blair A Jobe, MD
First Name & Middle Initial & Last Name & Degree
Kirsten Newhams, MD, MPH

12. IPD Sharing Statement

Learn more about this trial

Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans

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