NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
NCT ID: NCT01870869
Last Updated: 2020-06-22
Study Results
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View full resultsBasic Information
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TERMINATED
NA
1951 participants
INTERVENTIONAL
2013-05-29
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Augmentation
Women who had breast augmentation with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Surgical implant
Reconstruction
Women who had breast reconstruction with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Surgical implant
Revision-Augmentation
Women who had revision of previous breast augmentation with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Surgical implant
Revision-Reconstruction
Women who had revision of previous breast reconstruction with NATRELLE® 410 implants.
Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Surgical implant
Interventions
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Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Surgical implant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Present with 1 or more of the following conditions:
* Primary breast augmentation (i.e., no previous breast implant surgery) indicated for participant dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
* Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma, (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when permanent implants are placed in the reconstructed breast)
* Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants
* Has adequate tissue available to cover implants
Exclusion Criteria
* Has an existing carcinoma of the breast, without mastectomy
* Has an abscess or infection in the body at the time of enrollment
* Is pregnant or nursing
* Has any disease, including uncontrolled diabetes (e.g., hemoglobin A1c (HbA1c) \> 8%), that is clinically known to impact wound healing ability
* Shows tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration
* Has or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
* Shows psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
* Is not willing to undergo further surgery for revision, if medically required
18 Years
FEMALE
Yes
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Schumacher
Role: STUDY_CHAIR
Allergan
Locations
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Anthony Griffin
Beverly Hills, California, United States
Laurence Berkowitz
Campbell, California, United States
Mary Powers
Long Beach, California, United States
Roy Hong
Palo Alto, California, United States
Eric Bachelor
Pleasanton, California, United States
Douglas Reavie
San Diego, California, United States
Steven Teitelbaum
Santa Monica, California, United States
Tad Heinz
Colorado Springs, Colorado, United States
Gary Snider
Denver, Colorado, United States
Terrence Murphy
Englewood, Colorado, United States
Orlando De Lucia
Farmington, Connecticut, United States
Lewis Berger
Tampa, Florida, United States
Gerard Mosiello
Tampa, Florida, United States
James Namnoum
Atlanta, Georgia, United States
Peter Johnson
Des Plaines, Illinois, United States
Stephen Madry
Elk Grove Village, Illinois, United States
Janet Turkle
Carmel, Indiana, United States
Bruce Van Natta
Indianapolis, Indiana, United States
Christine Kelley-Patteson
Indianapolis, Indiana, United States
Brad Storm
Olathe, Kansas, United States
Julene Samuels
Louisville, Kentucky, United States
Timothy Mickel
Monroe, Louisiana, United States
Paul Davis
Shreveport, Louisiana, United States
Bradley Bengtson
Grand Rapids, Michigan, United States
John Renucci
Grand Rapids, Michigan, United States
Steven Morris
Midland, Michigan, United States
Charles Nathan
Chesterfield, Missouri, United States
Herluf Lund Jr.
Chesterfield, Missouri, United States
Patricia McGuire
Creve Coeur, Missouri, United States
Schuyler Meltis
Hannibal, Missouri, United States
Perry Johnson
Omaha, Nebraska, United States
Perry Johnson
Omaha, Nebraska, United States
Peter Hyans
Berkeley Heights, New Jersey, United States
Isaac Starker
Florham Park, New Jersey, United States
Peter Hetzler
Little Silver, New Jersey, United States
Marc Alan Drimmer
Princeton, New Jersey, United States
Caroline Glicksman
Sea Girt, New Jersey, United States
Lloyd Gayle
New York, New York, United States
John Sherman
New York, New York, United States
Tracy Pfeifer
New York, New York, United States
Robert Jacobs
Port Jefferson Station, New York, United States
John Decorato
Staten Island, New York, United States
Raymond Isakov
Cleveland, Ohio, United States
Craig Colville
Toledo, Ohio, United States
Frank Barone
Toledo, Ohio, United States
Derek Shadid
Oklahoma City, Oklahoma, United States
Robert Hein
Oklahoma City, Oklahoma, United States
Mark Jewell
Eugene, Oregon, United States
John Lettieri
Spartanburg, South Carolina, United States
Kristina D. O'Shaughnessy
Nashville, Tennessee, United States
Patrick Maxwell
Nashville, Tennessee, United States
William Carpenter
Dallas, Texas, United States
Jeffrey Friedman
Houston, Texas, United States
Natan Yaker
Plano, Texas, United States
William Adams
University Park, Texas, United States
Gloria Duda
McLean, Virginia, United States
Gavin Dry
Bellevue, Washington, United States
Allen Gabriel
Vancouver, Washington, United States
Countries
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Other Identifiers
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410CAXL-001
Identifier Type: -
Identifier Source: org_study_id
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