Recruiting

FlexHD® Pliable

Sponsor:

Musculoskeletal Transplant Foundation

Code:

NCT06797258

Conditions

Implant Based Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

Interventions

FlexHD® Pliable

No intervention

Study Details

Brief summary:

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

Conditions

Implant Based Breast Reconstruction

Study ID

NCT06797258

Start date

Mar 26, 2025

Status verified date

Mar, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

259 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

FlexHD® Pliable

Interventions

FlexHD® Pliable

Acellular Dermal Matrix

No intervention

Historical Control Arm

Primary outcome measure

  • Frequency of major complication [ Time Frame: 12 months ]
  • Frequency of reconstructive failure [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Jonathan Heistein, MD Plastic & Reconstructive Surgery

Recruiting

Fort Worth, Texas, United States, 76092

Contacts

Office

(817) 820-0000

More Information

Sponsor

Musculoskeletal Transplant Foundation

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Musculoskeletal Transplant Foundation on 2025-04-02.