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3D-Modeled Surgery for Breast Reconstruction

N/A

Waitlist Available

Led By Amir Ghaznavi

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months after reconstruction

Awards & highlights

Study Summary

This trial will study if using 3D models and Virtual Planning Surgery can improve outcomes for patients who need a mastectomy and breast reconstruction.

Who is the study for?

This trial is for individuals with confirmed breast cancer who need breast reconstruction after a mastectomy. They should be relatively healthy, with good organ function and blood counts within specific ranges. Participants must understand and agree to the study by signing consent forms. It's not for those who've had certain abdominal procedures, plan on radiation post-reconstruction, have severe illnesses or are pregnant/breastfeeding.Check my eligibility

What is being tested?

The study is testing if using Virtual Surgical Planning (VSP) and 3D medical models can improve outcomes in breast reconstruction surgery following a mastectomy. The goal is to see whether these advanced planning tools lead to better surgical results compared to standard methods.See study design

What are the potential side effects?

While the trial focuses on surgical outcomes rather than medication side effects, potential risks may include reactions related to IV contrast used in imaging or complications from surgery such as infection or issues with wound healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months after reconstruction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months after reconstruction

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after reconstruction for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean dissection time

Mean operative time

Secondary outcome measures

Aesthetic outcomes as measured by the Harris scale

Donor site complications

Incidence of fat necrosis as measured by a grading system

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 3-D virtual planning and medical modeling of breastExperimental Treatment1 Intervention

3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction. Preoperative CT-Angiogram of the abdominal wall Volumetric analysis preformed 3D printed models made Pre operative BREAST-Questionnaires given Free tissue transfer performed: Operative/Dissection Time Recorded Flap/Abdominal donor site complications recorded Standard Digital Photography and Harris Scoring BREAST-Questionnaires given at 3, 6 months

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,902 Total Patients Enrolled

3 Trials studying Breast Reconstruction

45 Patients Enrolled for Breast Reconstruction

Amir GhaznaviPrincipal InvestigatorThe Cleveland Clinic

Media Library

3D medical models (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03949491 — N/A

Breast Reconstruction Research Study Groups: 3-D virtual planning and medical modeling of breast

Breast Reconstruction Clinical Trial 2023: 3D medical models Highlights & Side Effects. Trial Name: NCT03949491 — N/A

3D medical models (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03949491 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this research endeavor?

"The primary purpose of this trial is to calculate the mean dissection time over a period of 6 months following reconstruction. Secondary measurements comprise aesthetic outcomes, as assessed by the Harris scale (1-4: higher scores signify worse effects); patient satisfaction, evaluated via BREAST-Q scores (4-16: larger values denote greater contentment with breasts); and incidence of fat necrosis, categorised according to a grading system from Grade I - V (higher grades represent poorer results)."

Answered by AI

Are there any available openings for participants in this research trial?

"According to information posted on clinicaltrials.gov, patient recruitment for this trial has closed since its last update on June 6th 2022. However, there are 23 other studies actively searching for participants at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling

2020. "Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03949491.