Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-30 @ 5:09 AM
Study NCT ID:
NCT04646057
Status:
UNKNOWN
Last Update Posted:
2024-04-18
First Post:
2020-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DuraSorb® in Prosthetic Breast Reconstruction
Sponsor:
Surgical Innovation Associates, Inc.
Organization:
Study Overview
Official Title:
The Safety and Effectiveness of DuraSorb® for Reinforcement in Patients Undergoing Prosthetic Breast Reconstruction
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.
Detailed Description:
Plastic surgeons have a variety of biologic and synthetic mesh available for use. However, no mesh has adequately evaluated safety and effectiveness for FDA approval or clearance for use in breast reconstruction. Therefore, no mesh is an appropriate comparator for a randomized clinical study.
This multi-center, prospective, clinical study with matched historical controls of total submuscular 2-stage breast reconstructions with no mesh will evaluate the safety and effectiveness of DuraSorb® monofilament surgical mesh when implanted in subjects undergoing 2-stage breast reconstruction.
Women scheduled for mastectomy and immediate 2-stage breast reconstruction will sign informed consent and satisfy eligibility criteria prior to the first stage of surgery and DuraSorb® implantation.
Maximum study follow-up is through one year after definitive reconstruction.
This multi-center, prospective, clinical study with matched historical controls of total submuscular 2-stage breast reconstructions with no mesh will evaluate the safety and effectiveness of DuraSorb® monofilament surgical mesh when implanted in subjects undergoing 2-stage breast reconstruction.
Women scheduled for mastectomy and immediate 2-stage breast reconstruction will sign informed consent and satisfy eligibility criteria prior to the first stage of surgery and DuraSorb® implantation.
Maximum study follow-up is through one year after definitive reconstruction.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: