Last updated: November 29, 2023
Sponsor: Establishment Labs
Overall Status: Active - Recruiting
Phase
N/A
Condition
Breast Reconstruction
Breast Cancer
Cancer
Treatment
Motiva Flora® Tissue Expander
Clinical Study ID
NCT06146231
CIP-001000
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Genetically female, aged 18 years or older.
- Subjects who had provided written informed consent form.
- The participant needs tissue expansion as part of breast reconstruction treatment,which may include immediate reconstruction.
- Clinical condition to allow reverse expansion breast reconstruction, at theinvestigator's discretion.
- Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeoncriteria.
- Complete radiotherapy and chemotherapy at least one year before surgery.
- BMI between 18.5 and 30.0 (average classified weight).
- Physical and cognitive capacity to understand and follow the surgeon'srecommendations.
- To be able and willing to comply with all study requirements, including attendingfollow-up appointments. Only Sub study participants
- Provide additional consent to undergo an MRI with contrast.
Exclusion
Exclusion Criteria:
- Current pregnancy or lactation, or full-term pregnancy or lactation at any pointduring the clinical investigation.
- Abnormal hematological and biochemical values after chemotherapy.
- High surgical risk according to the investigator.
- Breast width larger than 18 cm
- Tumor residues in or near the area where tissue expansion is performed.
- Subjects with metastatic breast cancer
- Significant Breast ptosis or poor skin quality
- Participants who do not have adequate tissue at the intended site for expansion, atthe surgeon's discretion, due to previous radiotherapy, ulceration, vascularinvolvement, history of impaired wound healing, or mastectomy scar deformity.
- Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts,or radical resection of the pectoralis major muscle.
- Current or previous infection in the area where the expansion occurs.
- Any condition that impedes magnetic resonance imaging (MRI), including implanted metaldevice, claustrophobia, or other ailments that would prohibit MRI scan.
- Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromisedparticipants due to immunosuppressive or steroid therapy.
- History of silicone sensitivity.
- Active smokers
- Previous attempts of breast reconstruction
- Subjects who, in the opinion of the investigator, are considered part of anyvulnerable population
- Subjects with affiliation to the Sponsor, sites or investigators, including relatives.
- Participants who do not live in the procedure's country make it impossible to assistin follow-up visits.
- Subjects who are participating in other investigation(s) which may affect the outcomesor ability to comply follow-up requirements of this study
Study Design
Total Participants: 66
Treatment Group(s): 1
Primary Treatment: Motiva Flora® Tissue Expander
Phase:
Study Start date:
August 18, 2023
Estimated Completion Date:
April 30, 2027
Connect with a study center
Universitair Ziekenhuis Gent
Ghent,
BelgiumActive - Recruiting
Hospital Universitario San Ignacio
Bogotá,
ColombiaSite Not Available
Hospital UNIBE
San José,
Costa RicaSite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona,
SpainActive - Recruiting
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