RECRUITING

Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

Conditions

Capsular Contracture Associated With Breast Implant Capsular Contracture Grade III Capsular Contracture Grade IV

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.

Official Title

A Prospective, Randomized, Controlled, Multi-Center Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

Quick Facts

Study Start:2024-12-12

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05945329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 66 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Genetically female ≥22 and ≤66 years of age; 2. Breast augmentation subject with capsular contracture (Baker grade III or IV); 3. Desired a new implant with no more than a 25% increase in implant size (not to exceed a volume increase greater than 150cc compared to the existing implant); 4. Planned revision approach via inframammary fold (IMF) incision; 5. Willing and able to comply with the study procedures including the 2-year follow-up visit; 6. Lives within 3 hours driving distance from the investigator site; and, 7. Provision of signed and dated informed consent form.	1. BMI \<18 or \>35 2. Existing and/or replacement implant size \> 800 cc 3. Had ≥2 capsular contracture revisions on the breast(s) intended for treatment 4. Has an extra-capsular rupture (breast implant silicone gel or saline has leaked outside of the capsule) in breast(s) intended for treatment 5. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment. 6. Abnormal findings on diagnostic imaging within 1-year of study enrollment (mammogram for patients ≥35 years old; MRI for patients \<35 years old or breast ultrasound if MRI is contraindicated) 7. Has symptoms consistent with Breast Implant Illness (BII)Systemic Symptoms Associated with Breast Implants (SSBI) 8. Infection present in the breast (day of surgery exclusions are noted in Section 5.3) 9. Current or recent breast feeding (within 3-months or enrollment) or history of mastitis within the 6-months prior to enrollment 10. Prior or current diagnosis of breast cancer 11. Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results 12. Has undergone prior chest radiation treatment 13. Has received chemotherapy within the last 12 months 14. Current or recent (within 1-year of enrollment) alcohol/substance abuse 15. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.) 16. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) 17. Planned use of another type of matrix (such as ADM) in addition to GalaFLEX LITE™ 18. Current or planned use of medical (e.g. Singulair), physical (e.g. massage), or device-assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s) 19. Any medical condition that, in the opinion of the investigator, may be associated with unduly high risk of intra- or post-operative complications (e.g., insulin-dependent diabetes, autoimmune disease, connective tissue disorder, chronic lung or severe cardiovascular disease) 20. Concurrent or planned (within the 2-year follow-up time period) elective cosmetic breast operation to the treated breast (e.g., autologous fat transfer, mastopexy, or implant size changes) 21. Currently enrolled or has plans to enroll in another clinical study that would interfere with this study, unless it is a retrospective or observational study 22. Is pregnant or plans to become pregnant during the study period 23. Known allergy to tetracycline hydrochloride and kanamycin sulfate 24. Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes 25. Subject will not remain under the care of the investigator for all plastic surgery procedures while enrolled in the study 26. Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted) 27. Confirmed diagnosis of the following rheumatic diseases or syndromes: systemic lupus erythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome 28. Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study 29. Subject has an implant that was never commercially available in the United States (had their breast augmentation in another country) 30. Has been implanted with any silicone implant other than breast implants 31. Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications 32. Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping to conduct the study or are directly related to anyone that works for BD or any of their subsidiaries or the study surgeons. -

Inclusion Criteria

Exclusion Criteria

1. Genetically female ≥22 and ≤66 years of age;
2. Breast augmentation subject with capsular contracture (Baker grade III or IV);
3. Desired a new implant with no more than a 25% increase in implant size (not to exceed a volume increase greater than 150cc compared to the existing implant);
4. Planned revision approach via inframammary fold (IMF) incision;
5. Willing and able to comply with the study procedures including the 2-year follow-up visit;
6. Lives within 3 hours driving distance from the investigator site; and,
7. Provision of signed and dated informed consent form.

1. BMI \<18 or \>35
2. Existing and/or replacement implant size \> 800 cc
3. Had ≥2 capsular contracture revisions on the breast(s) intended for treatment
4. Has an extra-capsular rupture (breast implant silicone gel or saline has leaked outside of the capsule) in breast(s) intended for treatment
5. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment.
6. Abnormal findings on diagnostic imaging within 1-year of study enrollment (mammogram for patients ≥35 years old; MRI for patients \<35 years old or breast ultrasound if MRI is contraindicated)
7. Has symptoms consistent with Breast Implant Illness (BII)Systemic Symptoms Associated with Breast Implants (SSBI)
8. Infection present in the breast (day of surgery exclusions are noted in Section 5.3)
9. Current or recent breast feeding (within 3-months or enrollment) or history of mastitis within the 6-months prior to enrollment
10. Prior or current diagnosis of breast cancer
11. Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results
12. Has undergone prior chest radiation treatment
13. Has received chemotherapy within the last 12 months
14. Current or recent (within 1-year of enrollment) alcohol/substance abuse
15. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.)
16. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
17. Planned use of another type of matrix (such as ADM) in addition to GalaFLEX LITE™
18. Current or planned use of medical (e.g. Singulair), physical (e.g. massage), or device-assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s)
19. Any medical condition that, in the opinion of the investigator, may be associated with unduly high risk of intra- or post-operative complications (e.g., insulin-dependent diabetes, autoimmune disease, connective tissue disorder, chronic lung or severe cardiovascular disease)
20. Concurrent or planned (within the 2-year follow-up time period) elective cosmetic breast operation to the treated breast (e.g., autologous fat transfer, mastopexy, or implant size changes)
21. Currently enrolled or has plans to enroll in another clinical study that would interfere with this study, unless it is a retrospective or observational study
22. Is pregnant or plans to become pregnant during the study period
23. Known allergy to tetracycline hydrochloride and kanamycin sulfate
24. Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes
25. Subject will not remain under the care of the investigator for all plastic surgery procedures while enrolled in the study
26. Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted)
27. Confirmed diagnosis of the following rheumatic diseases or syndromes: systemic lupus erythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
28. Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study
29. Subject has an implant that was never commercially available in the United States (had their breast augmentation in another country)
30. Has been implanted with any silicone implant other than breast implants
31. Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications
32. Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping to conduct the study or are directly related to anyone that works for BD or any of their subsidiaries or the study surgeons. -

Contacts and Locations

Study Contact

Niccole Diaz

CONTACT

407-694-0553

Niccole.Diaz@bd.com

Peter Fayek, M.D

CONTACT

714-616-1421

Peter.Fayek@bd.com

Study Locations (Sites)

The Practice Plastic Surgery

Beverly Hills, California, 90210

United States

Newport Plastic and Reconstructive Surgery Associates

Newport Beach, California, 92660

United States

Billington Plastic Surgery

Saint Petersburg, Florida, 33710

United States

Plastic Surgery Institute of New York

New York, New York, 10036

United States

H/K/B Surgery

Huntersville, North Carolina, 28078

United States

Essential Medical Research

Tulsa, Oklahoma, 74137

United States

Collaborators and Investigators

Sponsor: C. R. Bard

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12

Study Completion Date2027-01

Study Record Updates

Study Start Date2024-12-12

Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

Capsular Contracture Associated With Breast Implant
Capsular Contracture Grade III
Capsular Contracture Grade IV