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Recruiting

NCT Number: NCT06797258

FlexHD® Pliable Investigation 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

Recruiting

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Key information

Conditions

Implant Based Breast Reconstruction

Age range

22 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jonathan Heistein, MD Plastic & Reconstructive Surgery

Fort Worth, Texas, 76092, United States

Location status: Recruiting

Location contact

Office

CONTACT

(817) 820-0000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FlexHD® Pliable

Device

Acellular Dermal Matrix

No intervention

Other

Historical Control Arm

Primary outcomes

  1. Frequency of major complication

    Time frame: 12 months

    Complications that require additional hospitalization or reoperation

  2. Frequency of reconstructive failure

    Time frame: 12 months

    Removal/explantation of the breast implant

Secondary outcomes

  1. Change in patient reported outcomes

    Time frame: 12 months

    Change from baseline in patient reported outcomes as measured by the BREAST-Q (Scoring 0-100; 0=less satisfaction; 100= greater satisfaction)

  2. Pain

    Time frame: 12 months

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

  3. Adverse events

    Time frame: 12 months

    Reported adverse events

Sponsors and collaborators

Lead sponsor

Musculoskeletal Transplant Foundation

Other

Collaborators

  • Bruder Consulting International, LLC
  • MCRA (an IQVIA business)

Registry information

Official study title

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

Acronym: SHAPE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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