NCT06797258 FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
| NCT ID | NCT06797258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Musculoskeletal Transplant Foundation |
| Condition | Implant Based Breast Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 259 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 259 participants in total. It began in 2025-03-26 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
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
Frequently Asked Questions
Who can join the NCT06797258 clinical trial?
This trial is open to female participants only, aged 22 Years or older, studying Implant Based Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06797258 currently recruiting?
Yes, NCT06797258 is actively recruiting participants. Visit ClinicalTrials.gov or contact Musculoskeletal Transplant Foundation to inquire about joining.
Where is the NCT06797258 trial being conducted?
This trial is being conducted at Fort Worth, United States.
Who is sponsoring the NCT06797258 clinical trial?
NCT06797258 is sponsored by Musculoskeletal Transplant Foundation. The trial plans to enroll 259 participants.