Breast Reconstruction Clinical Trial
Official title:
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
Verified date | June 2020 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
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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