NCT05817175 International Prospective REgistry on Pre-pectorAl Breast REconstruction
| NCT ID | NCT05817175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,236 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2027-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,236 participants in total. It began in 2023-09-12 with a primary completion date of 2027-09-10.
⚠ 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
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.
Eligibility Criteria
Inclusion Criteria: * Female patients older than 18 years old * Signed informed consent form * Patients undergoing mono or bilateral therapeutic mastectomy * Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh Exclusion Criteria: * Male patients * Patients not suitable for surgical treatment * Patients undergoing subpectoral reconstruction * Patients undergoing breast reconstruction with autologous tissue.
Contact & Investigator
Oreste D Gentilini, Dr
STUDY CHAIR
IRCCS San Raffaele
Frequently Asked Questions
Who can join the NCT05817175 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05817175 currently recruiting?
Yes, NCT05817175 is actively recruiting participants. Contact the research team at gentilini@eubreast.com for enrollment information.
Where is the NCT05817175 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Al Mansurah, Egypt, Al Mansurah, Egypt, Athens, Greece and 7 additional locations.
Who is sponsoring the NCT05817175 clinical trial?
NCT05817175 is sponsored by IRCCS San Raffaele. The principal investigator is Oreste D Gentilini, Dr at IRCCS San Raffaele. The trial plans to enroll 1,236 participants.
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