Photoacoustic Computed Tomography for Pre-Operative Reconstructive Flap Angiography

NCT04783272 | Withdrawn FDA Device

• 1 other identifier: STUDY00000648
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a new non-invasive imaging technology, called Photoacoustic Computed Tomography (PACT), can be used in the pre-operative setting to better visualize the blood supply of reconstructive flaps used in Plastic Surgery.

Conditions

Other Reconstructive Surgery; Plastic Surgery

Keywords

flap reconstructive surgery; Plastic Surgery; Photoacoustic Computed Tomography (PACT)

Outcome Measures

Primary Outcomes (2)

• PACT Patient Comfort Questionnaire

  The data is ordinal and discrete (Likert scale). The scale is 1 to 5 where 1 is the worst and 5 is the best.

  This questionnaire will be completed by patient at the time of the PACT Imaging visit. Imaging visit will occur after the initial visit and before surgery up to 4 months.

• Vascular Imaging Modality for Flap Reconstructive Surgery Questionnaire

  The data is ordinal and discrete (Likert scale). The scale is 1 to 5 where 1 is the worst and 5 is the best.

  This questionnaire will be completed by Dr. Edward Ray immediately following surgery.

Study Arms (1)

Treatment

EXPERIMENTAL

Photoacoustic Computed Tomography (PACT) Imaging

Diagnostic Test: Photoacoustic Computed Tomography (PACT) Imaging

Interventions

Photoacoustic Computed Tomography (PACT) Imaging DIAGNOSTIC_TEST

PACT will be completed prior surgery.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients above the age of 18 who are planned to undergo non-urgent flap reconstructive surgery, specifically either an abdominally-based flap or an ALT flap, will be study candidates.

You may not qualify if:

• Patients who require urgent or emergent flap reconstructive surgery, have undergone prior abdominally-based or ALT flap reconstructive surgery, who cannot receive ionizing radiation (required for CTA), who cannot receive iodinated intravenous contrast (required for CTA), and whose weight exceeds 300lbs (weight limit of PACT machine) will be excluded from the study.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Edward Ray, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 5, 2021
• Study Start: June 2, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

US (1)