Near-Infrared Perfusion During Minimally Invasive Thoracic Surgery Download

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a prospective, (NSR), single-center feasibility study of the Olympus VE2 NIR Imaging System to assess perfusion using NIR during minimally invasive esophagectomy and pulmonary segmentectomy. The aims of the study are:

1. To utilize NIR intraoperative imaging with the Olympus VE2 NIR Imaging System to: i. Characterize gastric conduit perfusion during esophagectomy and, ii. Identify segmental anatomy during sublobar pulmonary resection (segmentectomy) after intraoperative, intravenous delivery of low-dose 0.15 mg/kg of ICG.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Olympus

Criteria

Inclusion Criteria:

-Subject has a suspicious lung lesion for which a minimally invasive segmentectomy is planned -OR- sub-ject has an esophageal lesion for which an esophagectomy is planned -

• Subject is 18 years of age or older

• Subject is willing and able to provide informed consent

Exclusion Criteria:

• Subject is not eligible for surgical resection as determined by the treating physician

• Subject has known or suspected allergy to Iodine, shellfish or intravenous contrast

• Subject is not eligible or considered high risk for surgical resection as determined by pre-operative spirometry

• Subject is female and of childbearing age who is currently pregnant or who is planning to become pregnant within the study

• Subject is unable and unwilling to provide informed consent

• Subject has liver disease or is taking drugs impact liver metabolism.