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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
OviTex PRS
DeviceA multi-layer construct of extracellular matrix (ECM) derived from ovine forestomach and embroidered with polymer filament.
Treatment groups
235 Participants
are divided into 1 treatment groupGroup A: OviTex PRSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Reconstructive Failure Rate
Time frame
From enrollment to 12 months2
Major Complication Rate
Time frame
From enrollment to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov