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Implant Based Breast ReconstructionSHAPENCT06797258

FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

A study testing FlexHD® Pliable in people with Implant Based Breast Reconstruction, run by Musculoskeletal Transplant Foundation at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique Read more about this study

Who is it for?
Ages 22 years and older, women only
Conditions the study is for
Implant Based Breast Reconstruction
What is being tested?
FlexHD® Pliable
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
259 participants
Where
1 siteUnited States
Study dates
26 Mar 2025to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Jonathan Heistein, MD Plastic & Reconstructive Surgery

    Fort Worth, Texas, 76092

    Office, (817) 820-0000

    Recruiting

Other trials in United States

About this study

Official title: Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction

Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique

Being tested
FlexHD® Pliable, No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlexHD® PliableDevice

    Acellular Dermal Matrix

  • No interventionOther

    Historical Control Arm

Study groups in NCT06797258
Study groupRoleWhat they receive
Treatment ArmExperimentalFlexHD® Pliable
Receives: Device: FlexHD® Pliable; Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of major complication

    Complications that require additional hospitalization or reoperation

    Measured: 12 months

  2. Frequency of reconstructive failure

    Removal/explantation of the breast implant

    Measured: 12 months

Secondary outcomes (3)

  1. 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)

    Measured: 12 months

  2. Pain

    Pain scores as measured by the Numerical Pain Rating Scale (NPRS) (Scoring 0-10; 0=no pain; 10= worst imaginable pain)

    Measured: 12 months

  3. Adverse events

    Reported adverse events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start26 Mar 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
259 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06797258
Sponsor's protocol ID
MTF 2024-10-IDE
Acronym
SHAPE
Status last verified
Mar 2025
First submitted
22 Jan 2025
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing FlexHD® Pliable in people with Implant Based Breast Reconstruction, run by Musculoskeletal Transplant Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of major complication (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06797258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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