The SeriScaffold® Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery in Europe

NCT01389232 | Completed Results

• 1 other identifier: SURE-002
• Study Type: interventional
• Target: 104
• Locations: 4 countries
• Sites: 5

Brief Summary

This is a post-market study of the use of SeriScaffold® for soft tissue support and repair in breast reconstruction surgery.

Conditions

Soft Tissue Support and Repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Investigator Satisfaction With Seri® Surgical Scaffold on an 11-Point Scale

  Month 3, Month 12, Month 18, Month 24

• Investigator Assessment of Ease of Use of Seri® Surgical Scaffold on a 5-Point Scale

  Immediately Following Stage 1 Surgery

• Breast Anatomy Measurements

  Preoperative, First Postoperative, Month 3, Month 6, Month 12, Month 18, Month 24

• Subject Satisfaction With Breasts on a 5-Point Scale

  Baseline, Month 6, Month 12, Month 18, Month 24

Study Arms (1)

SeriScaffold® Surgical Scaffold

EXPERIMENTAL

Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.

Device: SeriScaffold® Surgical Scaffold

Interventions

SeriScaffold® Surgical Scaffold DEVICE

A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair

SeriScaffold® Surgical Scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sofregen Medical, Inc.: lead

Study Sites (5)

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Nottingham, United Kingdom

Location

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2015
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (2); IT (1); GB (1)