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Clinical Trial Summary

This research study will assess the ability of structured light imaging to recognize connective tissues commonly encountered during surgery, and will also develop best practices for structured light imaging use in the operating room to determine situations in which structured light may be most helpful in providing unique in-vivo tissue contrast and resolution for tissue identification, beyond what can be seen by the surgeon's eye or with standard cameras.


Clinical Trial Description

Study candidates will be patients ages 18 years or older who are undergoing surgical procedures where common and vital tissues will be exposed and visible. These tissues include skeletal muscle, adipose, nerve structures, fascia, tendon, ligaments, and some sub-classifications of each tissue type. The surgical procedures include, but are not limited to, orthopaedic surgery, spine surgery, tumor resections, breast surgery, neurosurgery, urological surgery, thoracic surgery, and general abdominopelvic surgery.

We will use a commercial system from Modulated Imaging, Inc. called Reflect RS™. The system is free standing and the imaging head is suspended on an articulating arm. We will configure the system for at least an 18-inch (45 cm) working distance to minimize interference with the surgical field.

The device will, at no time, come into contact with the patient.

We will set up the imaging system approximately 18 inches away from the surgical field. The device can be handheld or mounted on a boom. We will use the device to obtain one color image and one structured light image simultaneously. An investigator will operate the camera by control and will continually obtain images throughout the surgery as the dissection progresses. After surgery, the operating surgeon will identify the organs and tissue features on the color image. The labeled color image will then be compared to the structured light imaging and the structured light image will be interrogated for tissue and topographical data. ;


Study Design


Related Conditions & MeSH terms

  • Focus: to Assess the Ability of Structured Light Imaging to Recognize Connective Tissues in Surgery

NCT number NCT03488004
Study type Observational
Source Dartmouth-Hitchcock Medical Center
Contact
Status Enrolling by invitation
Phase
Start date February 22, 2018
Completion date December 31, 2019