NCT06027996 Melodi Matrix™ in Breast Reconstruction
| NCT ID | NCT06027996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Melodi Health, Inc. |
| Condition | Breast Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 702 participants |
| Start Date | 2024-08-09 |
| Primary Completion | 2027-12 |
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 702 participants in total. It began in 2024-08-09 with a primary completion date of 2027-12.
⚠ 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, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Eligibility Criteria
Inclusion Criteria: * Female. * Age 22 or older at the time of enrollment. * Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction. * Is able to and willing to comply with the study requirements and providing informed consent. Exclusion Criteria: * Has prior history of neoadjuvant radiotherapy. * Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site. * Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days. * Has a Body Mass Index (BMI) \< 14 or \> 40. * Is pregnant or is nursing; or plans to become pregnant during the course of the study. * Has any connective tissue/autoimmune disorder or rheumatoid disease. * Has known allergies to study device materials. * Is participating in another interventional research study that may interfere with study endpoints. * Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation. * Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study. * Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06027996 clinical trial?
This trial is open to female participants only, aged 22 Years or older, studying 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 NCT06027996 currently recruiting?
Yes, NCT06027996 is actively recruiting participants. Contact the research team at michele.hilmer@melodihealth.com for enrollment information.
Where is the NCT06027996 trial being conducted?
This trial is being conducted at Palo Alto, United States, Ann Arbor, United States, Rochester, United States, Staten Island, United States and 6 additional locations.
Who is sponsoring the NCT06027996 clinical trial?
NCT06027996 is sponsored by Melodi Health, Inc.. The trial plans to enroll 702 participants.