Clinical trial NCT05591053: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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)
Lead sponsor: Activ Surgical
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh Medical Center
name: West Penn Allegheny Health System
First posted: 2022-10-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Incidence of Adverse Events in 28 days following use of ActivSight™
timeFrame: 28 days
measure: Preparation time of ActivSight™.
timeFrame: 1 day
measure: Latency of display of ActivSight™.
timeFrame: 1 day
measure: Resolution and objectivity of display of ActivSight™.
timeFrame: 1 day
measure: Specificity of display of ActivSight™.
timeFrame: 1 day
measure: Usability of ActivSightTM by surgeon, as quantified by Likert scale.
timeFrame: 1 day
measure: Support personnel satisfaction with ActivSightTM, as quantified by Likert scale.
timeFrame: 1 day
measure: User feedback on utility of relative perfusion unit display versus color heatmap
timeFrame: 1 day
measure: Episodes of intraoperative decision change based on display
timeFrame: 1 day
measure: Usability of the device by surgeon and support personnel satisfaction;
timeFrame: 1 day
Secondary outcomes:
measure: Ability of ActivSightTM to display perfusion.
timeFrame: 1 day
measure: Ability of ActivSightTM to display blood vessels.
timeFrame: 1 day
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Dept of Cardiothoracic Surgery
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital / Allegheny Health Network
state: Pennsylvania
Study officials:
References: