The SurgiMend PRS Retrospective Study (NCT05182177) | Clinical Trial Compass
CompletedNot Applicable
The SurgiMend PRS Retrospective Study
Italy, Switzerland, United Kingdom84 participantsStarted 2022-01-31
Plain-language summary
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The patient has reviewed the ethics-approved consent form and has provided consent for data collection
. Subject is a female over the age of 18 at the time of index surgery (mastectomy)
. Subject had mastectomy performed for cancer or as a cancer prophylaxis
. The surgical plan included one of the following approaches:
. Immediate unilateral or bilateral prepectoral DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skinreducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
. Immediate unilateral or bilateral submuscular DTI or TE/I breast reconstruction following nipple-sparing, skin-sparing, or skin-reducing mastectomy with the use of SurgiMend® PRS or SurgiMend® PRS Meshed
. If subject received bilateral breast reconstruction, the subject must have received the same surgical technique for both breasts including the implantation of SurgiMend® PRS or SurgiMend® PRS Meshed
. If subject received unilateral breast reconstruction, there was no surgical intervention on the contralateral breast within 12 months post-operatively
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.