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Mesh Implant

DuraSorb® Mesh for Breast Reconstruction

N/A
Waitlist Available
Research Sponsored by Surgical Innovation Associates, Inc.
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 12 month follow-up
Awards & highlights

Study Summary

This trial compares outcomes of breast reconstructions that use mesh to support the implants to those that don't use mesh.

Who is the study for?
This trial is for women aged 22-70 planning to have breast reconstruction with a mesh after mastectomy. They must be able to attend all visits, understand the study, and consent. Exclusions include prior failed reconstructions or radiation at the site, extreme BMI values, certain medications, recent nicotine use, pregnancy plans during the study, and any health issues that increase surgery risks.Check my eligibility
What is being tested?
The trial is testing DuraSorb®, a type of surgical mesh used in breast reconstruction post-mastectomy. It compares outcomes like safety and effectiveness between patients receiving this new mesh versus those who had similar surgeries without it.See study design
What are the potential side effects?
While specific side effects are not listed here, surgical meshes can typically cause complications such as infection at the surgery site, pain or discomfort around the area where they're implanted, possible allergic reactions or rejection by body tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breast
Local Complications of Breast Reconstruction

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Group II: Historical Control ArmActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Surgical Innovation Associates, Inc.Lead Sponsor

Media Library

DuraSorb® (Mesh Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04646057 — N/A
Breast Reconstruction Research Study Groups: Treatment Arm, Historical Control Arm
Breast Reconstruction Clinical Trial 2023: DuraSorb® Highlights & Side Effects. Trial Name: NCT04646057 — N/A
DuraSorb® (Mesh Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04646057 — N/A

Frequently Asked Questions

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

How many locales in the U.S. are utilizing this trial?

"Currently, 6 sites are recruiting volunteers for this experiment. These locations include Chicago, Boston and Houston in addition to 3 other cities; thus making it essential to select the closest one available so as to abate any necessary travel burdens."

Answered by AI

Does this research study admit participants over 30 years of age?

"Per the stated requirements, those eligible for enrollment must be between 22 and 70 years of age."

Answered by AI

Are new participants still being sought for this research project?

"According to information available on clinicaltrials.gov, this medical trial is actively accepting participants. The initial posting was dated the 15th of January 2021, with edits made as recently as September 2022."

Answered by AI

Who can be considered as eligible participants in this experiment?

"Individuals aged 22 to 70, with a diagnosis of breast cancer can apply for this trial. The total number of recruited participants is planned to reach 180."

Answered by AI

What is the scope of participation in this medical research?

"The sponsor, Surgical Innovation Associates, Inc., need a total of 180 eligible participants to carry out this trial. Northwestern University Feinberg School of Medicine in Chicago and Harvard Brigham and Women's Faulkner Hospital in Boston are two sites that will be involved with the execution of the study."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
What site did they apply to?
Harvard Brigham and Women's Faulkner Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
DuraSorb® in Prosthetic Breast Reconstruction
2021. "DuraSorb® in Prosthetic Breast Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04646057.
~4 spots leftby Jun 2024
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