Histological Analysis of Bellafill Injected Tissue at Various Time Points

NCT03327311 | Completed

• 1 other identifier: SUN-1502
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections.

Conditions

Histopathology

Keywords

No condition

Outcome Measures

Primary Outcomes (5)

• Histopathology

  Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.

  1 week

• Histopathology

  Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.

  1 month

• Histopathology

  Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.

  2 months

• Histopathology

  Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.

  3 months

• Histopathology

  Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.

  6 months

Study Arms (5)

Bellafill 1 week post-injection

n=2. Histopathology conducted 1 week post-injection

Device: Bellafill

Bellafill 1 month post-injection

n=2. Histopathology conducted 1 month post-injection

Device: Bellafill

Bellafill 2 months post-injection

n=2. Histopathology conducted 2 months post-injection

Device: Bellafill

Bellafill 3 months post-injection

n=2. Histopathology conducted 3 months post-injection

Device: Bellafill

Bellafill 6 months post-injection

n=2. Histopathology conducted 6 months post-injection

Device: Bellafill

Interventions

Bellafill DEVICE

Bellafill injected into site of pre-planned surgery (i.e., mini-abdominoplasty or redundant abdominal tissue removal) at two depths (dermis \& deep dermis).

Bellafill 1 month post-injection; Bellafill 1 week post-injection; Bellafill 2 months post-injection; Bellafill 3 months post-injection; Bellafill 6 months post-injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy Male and Female

You may qualify if:

• Female or male in good general health greater than 21 years of age. Female Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study.
• Subject must sign an IRB-approved Informed Consent Form, Photographic Release Form, California Experimental Subject's Bill of Rights Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed.
• Fitzpatrick skin type I-III.
• Planned adominoplasty surgery or post tummy- tuck surgery for redundant skin ("dog ear") removal surgery.
• Sufficient adominoplasty tissue or redundant skin ("dog ear") to allow for planned tissue procurement.
• Willing to comply with study protocols and complete the entire course of the study.

You may not qualify if:

• A female subject that is pregnant (positive UPT), breast-feeding, or who is of childbearing potential and not practicing a reliable method of birth control.
• Positive Bellafill Skin Test
• Any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to the proposed treatment or require interfering topical, systemic or surgical therapy.
• Have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed biopsy areas.
• History of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.).
• History of any previous injectable filler to the study treatment area.
• Have known susceptibility to keloid formation or hypertrophic scarring.
• History of Bleeding Disorders.
• Known hypersensitivity or previous allergic reaction to any of the components of the study device (including lidocaine or any amide-based anesthetic), or history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
• Undergone or planning to undergo desensitization injections to meat products.
• Unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
• Evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
• Use of an investigation device, biologic or drug in the past 30 days, or is current participation in an experimental drug, biologic or device trial.
• A condition or situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
• Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.

Sponsors & Collaborators

• Suneva Medical, Inc.: lead

Study Sites (1)

Call Suneva for Info

Danville, California, 94506, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue Pathology

Study Officials

• Nancy Seretta

  Suneva Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: October 31, 2017
• Study Start: August 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)