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New treatment option for Breast Cancer
Official title Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
ClinicalTrials.gov ID: NCT07510698
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction. The study will also look at quality of life, satisfaction with care, hospital resource use, and environmental impact.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- \ \ \ \
- Biologically female participants aged 18 to 75 years
- Oncologic or prophylactic indication for nipple-sparing mastectomy or skin-sparing mastectomy with immediate prepectoral reconstruction using a...
- Eligible for prepectoral reconstruction based on clinico-anatomic criteria, including adequate skin flap thickness, no relevant vascular compromise...
- American Society of Anesthesiologists (ASA) class I to III
You likely can't join if
- Chronic opioid use or treatment for pre-existing chronic pain that could interfere with assessment of the primary postoperative pain endpoint
- Contraindications to locoregional anesthesia techniques or to the awake/monitored anesthesia care protocol, including allergy to local anesthetics...
- Body mass index 35 or greater, or anatomic conditions contraindicating prepectoral reconstruction
- Previous high-dose chest radiotherapy with significant tissue compromise
- Pregnancy or breastfeeding
- Inability to guarantee planned follow-up or lack of adequate home support
See the full eligibility criteria
- \ \ \ \
- Biologically female participants aged 18 to 75 years
- Oncologic or prophylactic indication for nipple-sparing mastectomy or skin-sparing mastectomy with immediate prepectoral reconstruction using a definitive implant or tissue expander, including early breast cancer or a...
- Eligible for prepectoral reconstruction based on clinico-anatomic criteria, including adequate skin flap thickness, no relevant vascular compromise, body mass index less than 35, and no severe prior chest radiotherapy
- American Society of Anesthesiologists (ASA) class I to III
- Eligible for day surgery, defined by home autonomy, caregiver availability during the first 24 hours after surgery, and distance from the hospital compatible with home management
- Able and willing to complete telemedicine follow-up, including completion of protocol-required patient-reported outcome measures
- Written informed consent provided \ \
- Chronic opioid use or treatment for pre-existing chronic pain that could interfere with assessment of the primary postoperative pain endpoint
- Contraindications to locoregional anesthesia techniques or to the awake/monitored anesthesia care protocol, including allergy to local anesthetics, coagulation disorders, or inability to cooperate during surgery
- Body mass index 35 or greater, or anatomic conditions contraindicating prepectoral reconstruction
- Previous high-dose chest radiotherapy with significant tissue compromise
- Pregnancy or breastfeeding
- Inability to guarantee planned follow-up or lack of adequate home support
- Psychiatric or cognitive conditions preventing correct completion of patient-reported outcome measures
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Rome, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.