Clinical trial NCT04633512: Safety and Feasibility of ActivSightTM in Human
Official title: Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acute Cholecystitis
Colorectal Cancer
Diverticulitis, Colonic
Obesity, Morbid
Inflammatory Bowel Diseases
Keywords: laparoscopic
robot assisted surgery
gastrointestinal anastomoses
cholecystectomy
colorectal surgery
bariatric surgery
vascularity
perfusion
ICG
laser speckle contrast imaging
Lead sponsor: Activ Surgical
Sponsor class: INDUSTRY
Collaborators: name: The University of Texas Health Science Center, Houston
name: University at Buffalo
name: Ohio State University
First posted: 2020-11-18
Enrollment: 67
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 is 80 patients. Feasibility will be studied under two categories of operations: feasibility in patients undergoing intestinal anastomoses for bariatric or colorectal surgery (n=52); and feasibility in patients undergoing cholecystectomy (n=28).
Primary purpose: DEVICE_FEASIBILITY

Brief summary: ActivSightTM 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 safety and feasibility of ActivSightTM in displaying tissue perfusion in intestinal anastomoses including colorectal and bariatric surgery.

Secondary Objective: To determine the efficacy of ActivSightTM in; (1) displaying tissue vascularity and perfusion in comparison to indocyanine green (ICG) during gastrointestinal anastomoses; and (2) displaying biliary tree during laparoscopic cholecystectomy using ICG-based intraoperative cholangiography (IOC).

Detailed description: Design:

* This is a feasibility study designed to evaluate safety and feasibility of ActivSightTM in gastrointestinal anastomoses and cholecystectomy.
* Safety will be determined through clinical assessments and evaluation of any adverse event.
* Feasibility will be determined through technically successful completion of intended visualization.
* 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.
* Patients outcome and follow up to Postoperative day 28 will be monitored for clinical outcome.
* Target enrollment for the assessment of 80 patients; 52 evaluating intestinal anastomoses cases (including bariatric and colorectal cases); and 28 evaluating laparoscopic cholecystectomy. Stopping rules are triggered following the first 6 patients and a comparison group 6 patients in ICG-based treatment.

Eligibility criteria: Inclusion Criteria:

* All patients age \>= 18 years old undergoing laparoscopic or robot assisted intestinal anastomoses, or all patients age \>= 18 years old who are planned for laparoscopic cholecystectomy; 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.
* All patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy.
* 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.
* Any bariatric patients undergoing gastric sleeve or bypass.
* Any pediatric patient undergoing laparotomy for necrotizing enterocolitis
* 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 prothrombin time, tested prothrombin, and international normalized ratio \< 1.5 x upper limit of normal (ULN) (including patients on prophylactic anticoagulation)
* Renal function: Age-adjusted normal serum creatinine derived from Schwartz formula for estimating glomerular filtration rate by the Centers for Disease Control (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 gastrointestinal resection.
* 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, and pregnancy.
* Patients eligible for cholecystectomy, exclusion criteria include known allergy to iodides; known history of cholangitis, pancreatitis, prior common bile duct injury, coagulopathy or known, preexisting liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out.
* Patients currently in any investigational agents.

Primary outcomes:
measure: Incidence of Adverse Events in 28 days following use of ActivSightTM
timeFrame: 28 days
measure: Preparation time of ActivSightTM.
timeFrame: 1 day
measure: Latency of display of ActivSightTM.
timeFrame: 1 day
measure: Resolution of display of ActivSightTM.
timeFrame: 1 day
measure: Specificity of display of ActivSightTM.
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
Secondary outcomes:
measure: Ability of ActivSightTM to display perfusion.
timeFrame: 1 day
measure: Ability of ActivSightTM to display blood vessels.
timeFrame: 1 day
measure: Ability of ActivSightTM to display biliary tree.
timeFrame: 1 day
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Kaleida Health, University of Buffalo
state: New York
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Sugar Land
country: United States
facility: Memorial Hermann Sugar Land Hospital
state: Texas
Study officials:
References: