Soft Tissue Support and Repair Clinical Trial
| NCT number | NCT01389232 |
| Other study ID # | SURE-002 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 2011 |
| Est. completion date | February 2015 |
| Verified date | May 2021 |
| Source | Sofregen Medical, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.
| Status | Completed |
| Enrollment | 104 |
| Est. completion date | February 2015 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Be female, greater or equal to 18 years of age - Be willing to undergo immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant - Be willing to undergo mastectomy with healthy, well vascularized skin flaps anticipated by the surgeon - Be in good health other than breast pathology and be suited to general anesthesia and planned treatments Exclusion Criteria: - Have undergone breast radiation treatment and/or is preoperatively evaluated to require radiation treatment to the breast area during the course of the study - Have a known allergy to silk - Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability - Have undergone previous breast surgery with the exception of mastectomy, breast biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation - Have had a prior soft tissue support device implanted in the breast - Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Sofregen Medical, Inc. |
Germany, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | Month 6 | |
| Secondary | Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale | Investigator satisfaction after stage I surgery/implantation of SERI® Surgical Scaffold is evaluated on an 11-point scale, where 0=very dissatisfied to 10=very satisfied. | Month 3, Month 12, Month 18, Month 24 | |
| Secondary | Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale | Investigator assessment of ease of use of SERI® Surgical Scaffold is evaluated on a 5-point scale, where 1=very difficult to use to 5=very easy to use. | Immediately Following Stage 1 Surgery | |
| Secondary | Breast Anatomy Measurements | Breast anatomy measurements were taken at the following points: sternal notch to apex, sternal notch to inframammary fold, apex to inframammary fold, and medial mammary fold to lateral mammary fold. | Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24 | |
| Secondary | Subject Satisfaction With Breasts on a 5-Point Scale | Subject satisfaction with breasts is evaluated on a 5-point scale, where 1=very dissatisfied to 5=very satisfied. | Baseline, Month 6, Month 12, Month 18, Month 24 |