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Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction

NCT ID: NCT02033590

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Reconstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SERI® Surgical Scaffold

Group Type EXPERIMENTAL

Biodegradable (purified) surgical silk scaffold

Intervention Type DEVICE

Interventions

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Biodegradable (purified) surgical silk scaffold

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sofregen Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SURE-005

Identifier Type: -

Identifier Source: org_study_id