Structured Light Study

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

Official title:

An Assessment of Structured Light to Recognize Connective Tissues During Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03488004
• Other study ID #: D18051
• Secondary ID: 30763
• Status: Enrolling by invitation
• First received: March 28, 2018
• Last updated: March 28, 2018
• Start date: February 22, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Undergoing surgical procedures with a participating surgeon in which common and vital tissues will be exposed and visible.

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

Device:
• Modulated Imaging Reflect RS
We will obtain approximately 30 images of each of the 7 tissue types per patient

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structured light imaging assessment	To assess the ability of structured light imaging to recognize connective tissues commonly encountered during surgery.	During surgery
Secondary	Best practices for structured light imaging	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.	During surgery