HistopathologyNCT03327311
Histological Analysis of Bellafill Injected Tissue at Various Time Points
An observational study of Histopathology, run by Suneva Medical, Inc. at 1 site in United States.
Trial summary
This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Histopathology
- What is being tested?
- Bellafill
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Male and Female
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Analysis of Bellafill Injected Tissue at Various Time Points: A Proof of Concept Study
This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections.
Read the detailed description
Visit 1 (day 0): Subjects with pre-planned surgical treatment (mini-abdominoplasty or redundant abdominal tissue removal) will be enrolled and will receive a Bellafill Skin Test.
Visit 2 (Day 28): Each subject receives treatment with Bellafill into 2 identified rectangular treatment areas within the pre-planned surgical area (0.1cc injected in the upper dermis and 0.1cc injected in the deep dermis at the subcutaneous junction).
Visit 3 (1 Week, 1 Month, or 2 Months; or, 3 Months or 6 Months): The timing of Visit 3 (the final study visit) is dependent on the subject's type of pre-planned surgery. Subjects who will undergo abdominoplasty will attend Visit 3 at 1 Week, 1 Month or 2 Months after Visit 2. Subjects who will undergo removal of redundant skin (i.e., dog ear) will attend Visit 3 at 3 Months or 6 Months after Visit 2. Following surgical removal of Bellafill injection sites, histopathologic analyses will be conducted.
- Conditions
- Histopathology
- Being tested
- Bellafill
- Keywords
- No condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BellafillDevice
Bellafill injected into site of pre-planned surgery (i.e., mini-abdominoplasty or redundant abdominal tissue removal) at two depths (dermis \& deep dermis).
| Study group | Role | What they receive |
|---|---|---|
| Bellafill 1 week post-injection | n=2. Histopathology conducted 1 week post-injection Receives: Device: Bellafill | |
| Bellafill 1 month post-injection | n=2. Histopathology conducted 1 month post-injection Receives: Device: Bellafill | |
| Bellafill 2 months post-injection | n=2. Histopathology conducted 2 months post-injection Receives: Device: Bellafill | |
| Bellafill 3 months post-injection | n=2. Histopathology conducted 3 months post-injection Receives: Device: Bellafill | |
| Bellafill 6 months post-injection | n=2. Histopathology conducted 6 months post-injection Receives: Device: Bellafill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Measured: 1 week
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Measured: 1 month
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Measured: 2 months
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Measured: 3 months
Histopathology
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study startAug 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistopathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suneva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Seretta, Study director, Suneva Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327311
- Sponsor's protocol ID
- SUN-1502
- Status last verified
- Oct 2017
- First submitted
- 29 Dec 2015
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Analysis of Bellafill Injected Tissue at Various Time Points: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03327311
- Acronym / sponsor ID
- SUN-1502
- Conditions
- Histopathology
- Keywords
- No condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Suneva Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections.
Detailed description
Visit 1 (day 0): Subjects with pre-planned surgical treatment (mini-abdominoplasty or redundant abdominal tissue removal) will be enrolled and will receive a Bellafill Skin Test.
Visit 2 (Day 28): Each subject receives treatment with Bellafill into 2 identified rectangular treatment areas within the pre-planned surgical area (0.1cc injected in the upper dermis and 0.1cc injected in the deep dermis at the subcutaneous junction).
Visit 3 (1 Week, 1 Month, or 2 Months; or, 3 Months or 6 Months): The timing of Visit 3 (the final study visit) is dependent on the subject's type of pre-planned surgery. Subjects who will undergo abdominoplasty will attend Visit 3 at 1 Week, 1 Month or 2 Months after Visit 2. Subjects who will undergo removal of redundant skin (i.e., dog ear) will attend Visit 3 at 3 Months or 6 Months after Visit 2. Following surgical removal of Bellafill injection sites, histopathologic analyses will be conducted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bellafill 1 week post-injection | – | Device: Bellafilln=2. Histopathology conducted 1 week post-injection |
| Bellafill 1 month post-injection | – | Device: Bellafilln=2. Histopathology conducted 1 month post-injection |
| Bellafill 2 months post-injection | – | Device: Bellafilln=2. Histopathology conducted 2 months post-injection |
| Bellafill 3 months post-injection | – | Device: Bellafilln=2. Histopathology conducted 3 months post-injection |
| Bellafill 6 months post-injection | – | Device: Bellafilln=2. Histopathology conducted 6 months post-injection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Male and Female
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BellafillBellafill injected into site of pre-planned surgery (i.e., mini-abdominoplasty or redundant abdominal tissue removal) at two depths (dermis \& deep dermis). | Device | 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 |
Primary outcome
Histopathology
Time frame: 1 week
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Histopathology
Time frame: 1 month
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Histopathology
Time frame: 2 months
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Histopathology
Time frame: 3 months
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Histopathology
Time frame: 6 months
Histopathologic examination of tissue samples to characterize PMMA induced collagen production in the dermis and deep dermis tissue.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Seretta study director
Suneva Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Histopathology, run by Suneva Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathology (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.