Clinical trial · Interventional
Safety and Feasibility of ActivSightTM in Human
Safety and Feasibility of ActivSightTM Laser Speckle Imaging in Visualization of Tissue Perfusion and Vasculature in Human
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Cholecystitis | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Diverticulitis, Colonic | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
| Obesity, Morbid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ActivSight | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ActivSight Group
- description
- Patients undergoing intestinal anastomoses (colorectal and bariatric) with ActivSight (n=52) Patients undergoing cholecystectomy with ActivSight (n=28)
- interventionNames
- Device: ActivSight
Primary outcomes (7)
- measure
- Incidence of Adverse Events in 28 days following use of ActivSightTM
- timeFrame
- 28 days
- description
- To determine safety of ActivSightTM in patients undergoing intestinal anastomoses, as defined through clinical assessments and evaluation of use related adverse events intraoperatively and a routine follow up at 28 days following surgery. ActivSightTM will be deemed safe if 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available