Effectiveness and Safety of OviTex® PRS in Breast Reconstruction
ConditionBreast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22-75
SponsorTela Bio Inc
About this trial
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
Eligibility criteria
Qualifiers
Patient is a female between the ages of 22 - 75, inclusive, at the time of enrollment (e.g. date of index surgical procedure);
Patient is planned for a first-time immediate unilateral or bilateral DTI pre-pectoral breast reconstruction following mastectomy for cancer or as cancer prophylaxis;
Patient is not a current cigarette smoker;
Patient is willing and able to voluntarily sign the IRB approved Subject Informed Consent Form;
Disqualifiers
Patient has a BMI < 18.5 or > 35;
Patient is undergoing radical mastectomy;
Breast reconstruction plan includes hybrid implant coverage using another type of mesh (synthetic or ADM) or another autologous treatment such as large latissimus flap, abdominal flap or similar;
Breast reconstruction plan includes a custom sized breast implant, permanent breast implant greater than 800cc, and/or a permanent breast implant that is not FDA approved for use in breast reconstruction;
Trial design
Treatments tested in this trial
- OviTex PRS
Treatment groups
235 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov