NCT02033590

Brief Summary

The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

Same day

First QC Date

January 9, 2014

Last Update Submit

October 5, 2017

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of implant loss (SERI® and breast implant)

    52 weeks

Study Arms (1)

SERI® Surgical Scaffold

EXPERIMENTAL
Device: Biodegradable (purified) surgical silk scaffold

Interventions

Biodegradable (purified) surgical silk scaffoldDEVICE
SERI® Surgical Scaffold

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing to undergo immediate breast reconstruction following a skin-sparing or nipple sparing mastectomy with healthy, sufficiently thick, well-vascularized skin flaps, and the implantation of SERI® Surgical Scaffold and breast implant
  • Be female, between 18 and 65 years of age at the time of enrollment

You may not qualify if:

  • Have undergone prior radiation treatment on the study breast(s) and/or is preoperatively evaluated to require radiation treatment to the study breast(s) during the course of the study
  • Have undergone a skin reducing mastectomy
  • Have a BMI that is \<17 or ≥ 30
  • Predicted implant weight more than 500 grams
  • Have a known allergy to silk
  • Have an abscess or active infection at any location within one month prior to surgery
  • Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

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

January 9, 2014

First Posted

January 13, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

October 9, 2017

Record last verified: 2017-10