FlexHD® Pliable Investigation in Implant-Based Breast Rec... | NCT06797258

Studies
FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

NCT06797258

Sponsor

Musculoskeletal Transplant Foundation

Status

Recruiting

Last Update Posted

Apr 2, 2025Actual

Enrollment

259Estimated

Phase

Not Applicable

Conditions

Implant Based Breast Reconstruction

Interventions

FlexHD® Pliable
No intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2025Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Jan 22, 2025

First Submission Date that Met QC Criteria

Jan 22, 2025

First Posted Date

Jan 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 2, 2025Actual

Name	Class
MCRA (an IQVIA business)	UNKNOWN
Bruder Consulting International, LLC	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

259Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Arm	Experimental	FlexHD® Pliable	Device: FlexHD® Pliable Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FlexHD® Pliable	Device	Acellular Dermal Matrix	Treatment Arm
No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of major complication	Complications that require additional hospitalization or reoperation	12 months
Frequency of reconstructive failure	Removal/explantation of the breast implant	12 months

Secondary Outcomes

Measure	Description	Time Frame
Change in patient reported outcomes	Change from baseline in patient reported outcomes as measured by the BREAST-Q (Scoring 0-100; 0=less satisfaction; 100= greater satisfaction)	12 months
Pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females at least 22 years of age
Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
Willing to provide Informed Consent
Able to return for all required study visits
Must read and understand English language

Exclusion Criteria:

Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
Has a residual gross tumor at the intended reconstruction site
Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
Completed chemotherapy within 3 weeks prior to surgery
Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
Has a Body Mass Index (BMI) >35
Has used nicotine products within 1 month of screening
Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Jonathan Heistein, MD Plastic & Reconstructive Surgery	Recruiting	Fort Worth	Texas	76092	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided