Safety and Feasibility of ActivSightTM in Human

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Brief Title

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

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 40 patients; 26 evaluating intestinal
           anastomoses cases (including bariatric and colorectal cases); and 14 evaluating
           laparoscopic cholecystectomy. Stopping rules are triggered following the first 6
           patients and a comparison group 6 patients in ICG-based treatment.
    


Study Type

Interventional


Primary Outcome

Incidence of Adverse Events in 28 days following use of ActivSightTM

Secondary Outcome

 Ability of ActivSightTM to display perfusion.

Condition

Acute Cholecystitis

Intervention

ActivSight

Study Arms / Comparison Groups

 ActivSight Group
Description:  Patients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=26) Patients undergoing cholecystectomy with ActivSight (n=14)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

November 17, 2020

Completion Date

January 2024

Primary Completion Date

January 2024

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04633512

Organization ID

ACF0012020


Responsible Party

Sponsor

Study Sponsor

Activ Surgical

Collaborators

 The University of Texas Health Science Center, Houston

Study Sponsor

, , 


Verification Date

April 2021