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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01870869
Other study ID # 410CAXL-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 29, 2013
Est. completion date November 30, 2015

Study information

Verified date June 2020
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants for breast augmentation, reconstruction, or revision.


Recruitment information / eligibility

Status Terminated
Enrollment 1951
Est. completion date November 30, 2015
Est. primary completion date November 30, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts; or be planning to be implanted with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and meet the inclusion criteria listed below:

- Female, age 18 or older (age 22 or older for breast augmentation participants who are implanted under Protocol 410CAXL-001)

- 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:

For entry in this study, participants must have either been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and did not meet the exclusion criteria listed below or plan to undergo implantation with NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X- or L-Style Breast Implants in 1 or both breasts and does not meet the exclusion criteria listed below:

- Has an advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy

- 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

Study Design


Intervention

Device:
Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
Surgical implant

Locations

Country Name City State
United States James Namnoum Atlanta Georgia
United States Gavin Dry Bellevue Washington
United States Peter Hyans Berkeley Heights New Jersey
United States Anthony Griffin Beverly Hills California
United States Laurence Berkowitz Campbell California
United States Janet Turkle Carmel Indiana
United States Charles Nathan Chesterfield Missouri
United States Herluf Lund Jr. Chesterfield Missouri
United States Raymond Isakov Cleveland Ohio
United States Tad Heinz Colorado Springs Colorado
United States Patricia McGuire Creve Coeur Missouri
United States William Carpenter Dallas Texas
United States Gary Snider Denver Colorado
United States Peter Johnson Des Plaines Illinois
United States Stephen Madry Elk Grove Village Illinois
United States Terrence Murphy Englewood Colorado
United States Mark Jewell Eugene Oregon
United States Orlando De Lucia Farmington Connecticut
United States Isaac Starker Florham Park New Jersey
United States Bradley Bengtson Grand Rapids Michigan
United States John Renucci Grand Rapids Michigan
United States Schuyler Meltis Hannibal Missouri
United States Jeffrey Friedman Houston Texas
United States Bruce Van Natta Indianapolis Indiana
United States Christine Kelley-Patteson Indianapolis Indiana
United States Peter Hetzler Little Silver New Jersey
United States Mary Powers Long Beach California
United States Julene Samuels Louisville Kentucky
United States Gloria Duda McLean Virginia
United States Steven Morris Midland Michigan
United States Timothy Mickel Monroe Louisiana
United States Kristina D. O'Shaughnessy Nashville Tennessee
United States Patrick Maxwell Nashville Tennessee
United States John Sherman New York New York
United States Lloyd Gayle New York New York
United States Tracy Pfeifer New York New York
United States Derek Shadid Oklahoma City Oklahoma
United States Robert Hein Oklahoma City Oklahoma
United States Brad Storm Olathe Kansas
United States Perry Johnson Omaha Nebraska
United States Perry Johnson Omaha Nebraska
United States Roy Hong Palo Alto California
United States Natan Yaker Plano Texas
United States Eric Bachelor Pleasanton California
United States Robert Jacobs Port Jefferson Station New York
United States Marc Alan Drimmer Princeton New Jersey
United States Douglas Reavie San Diego California
United States Steven Teitelbaum Santa Monica California
United States Caroline Glicksman Sea Girt New Jersey
United States Paul Davis Shreveport Louisiana
United States John Lettieri Spartanburg South Carolina
United States John Decorato Staten Island New York
United States Gerard Mosiello Tampa Florida
United States Lewis Berger Tampa Florida
United States Craig Colville Toledo Ohio
United States Frank Barone Toledo Ohio
United States William Adams University Park Texas
United States Allen Gabriel Vancouver Washington

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants According to Investigator Satisfaction With Implants The investigator rated their satisfaction with the participant's breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants where the investigator responded: "Definitely satisfied" or "Somewhat satisfied" is reported. 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Primary Percentage of Participants According to Participant Satisfaction With Implants The participant rated their satisfaction with the breast implant for each breast on a 5-point scale (1=Definitely dissatisfied, 2=Somewhat dissatisfied, 3=Neither satisfied or dissatisfied, 4=Somewhat satisfied, 5=Definitely satisfied). If there was a different response for the left and right breasts the worst response was used. The percentage of participants who responded: "Definitely satisfied" or "Somewhat satisfied" is reported. 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Secondary Percentage of Participants With Local Complications Kaplan-Meier risk rates (estimation of the percentage of participants) of developing local complications is presented. Local complications collected in the study were: Asymmetry, Breast pain, Capsular contracture, Delayed wound healing, Fluid accumulation/seroma, Hematoma, Hypertrophic scarring/other abnormal scarring, Implant extrusion, Implant malposition, Implant palpability/visibility, Implant rupture, Infection, Redness, Skin rash, Swelling, Tissue/skin necrosis, Upper pole fullness, Wrinkling/rippling and Other complications . 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Secondary Percentage of Participants With Reoperations Kaplan-Meier risk rates (estimation of the percentage of participants) of reoperation is reported. 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
Secondary Percentage of Participants With Implant Removal With or Without Replacement Kaplan-Meier risk rates (estimation of the percentage of participants) of implant removal with or without replacement is reported. 5 years (followup after implantation that occurred between 06 May 2008 and 08 January 2015)
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