Trials / Unknown
UnknownNCT05591053
Utility and Usability of ActivSight™ Laser Speckle Imaging in Visualization of Tissue Perfusion and Blood Flow During Esophageal Surgery in Humans
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Activ Surgical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Esophagus Cancer
- Esophageal Cancer
- Esophageal Neoplasms
- Esophageal Diseases
- Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma
- Esophagus SCC
- Esophagus Tumor
- Esophagus Adenocarcinoma
- Esophagus Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ActivSight | Use of ActivSight in patients undergoing laparoscopic or robot assisted esophagectomy. |
Timeline
- Start date
- 2023-04-01
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2022-10-24
- Last updated
- 2024-02-21
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05591053. Inclusion in this directory is not an endorsement.