Moderate to Severe Midface Volume DeficitPhase 3VOLIDONCT05386030
Saypha® VOLUME Lidocaine for Midface Augmentation
A Phase 3 study testing saypha® VOLUME Lidocaine and Juvéderm® Voluma™ XC in people with Moderate to Severe Midface Volume Deficit, run by Croma-Pharma GmbH at 16 sites in United States.
Trial summary
The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC). Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Midface Volume Deficit
- What is being tested?
- saypha® VOLUME Lidocaine and Juvéderm® Voluma™ XC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 16 sitesUnited States
- Study dates
- 16 Aug 2022to 11 Dec 2024
- Phase
- Phase 3
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 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 22 - 75 years (inclusive) of age at Screening.
- Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), as assessed by the blinded investigator at the site.
- Females of childbearing potential must have a negative urine pregnancy test and must agree to use an effective method of birth control throughout the entire study. Male subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom).
- Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
- Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of entire investigation, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment).
- Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the investigator.
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- 1. Females of childbearing potential must have a negative urine pregnancy test
- Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point MVDSS), as assessed by the blinded evaluator at the site. The subject does not have to return to his baseline severity to be permitted to receive a repeat-treatment.
- Subject has completed initial treatment phase up to Visit 9 (SV1) and is willing to attend the study visits of the screening phase for repeat-treatment and repeat-treatment phase
- Females of childbearing potential must have a negative urine pregnancy test
- Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation
Who cannot join
- Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation
- History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
- History of hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic
- Tendency to keloid formation and/or hypertrophic scars and/ or have pigment disorders
- Known human immune deficiency virus-positive individuals
- Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area
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- Re-current (three times a year over the last year) herpes simplex in the treatment area
- History or presence of any autoimmune or connective tissue disease, or current treatment with immuno-modulating therapy
- Uncontrolled (or unstable) Diabetes mellitus or systemic diseases as per investigator discretion
- Previous facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) and semi-permanent / long-lasting fillers (e.g., poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA) filler) in the area of device application and during the entire investigation
- Implantation of dermal fillers in the treatment area within the preceding 24 months prior to Visit 1 (Screening) and during the entire investigation
- Subject has received any of the following aesthetic treatments in the midface area: e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion, mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet in the outer eye region) within the last 12 months prior to Visit 1, chemical peeling within the last three months prior to Visit 1 or is planning to undergo such procedures during entire investigation.
- Facial lipolysis, including submental fat treatments, within the previous 12 months prior to Visit 1 (Screening) and during the entire investigation
- Bariatric surgery within 12 months prior to Visit 1 (Screening) and during the entire investigation
- History of bleeding disorder and/or use of anticoagulant, antiplatelet, thrombolytic medication, or anti-inflammatory drugs (oral/injectable corticosteroids or non steroidal anti-inflammatory drugs, e.g., Motrin® or Advil®) or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., St. John's Wort, high doses of vitamin E supplements) from ten days pre- to seven days post injection (baseline treatment and touch-up treatment)
- Planned dental/oral surgery or modification (bridge-work, implants) within four weeks prior to each injection and to a minimum of four weeks post injection baseline treatment and touch-up treatment
- Beard longer than three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator
- Subjects who have one of the following assessments during the visual examinations at Visit 2 (Baseline): Snellen visual acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test.
- Subjects with active COVID-19 infection and subjects with symptoms consistent with COVID-19 infection including any other respiratory symptoms/illnesses within the past 14 days unless tested negative prior to Visit 1 (Screening)
- Any medical condition prohibiting the inclusion in the study according to the judgment of the treating investigator
- Previous enrollment in this clinical investigation
- Current participation in another clinical trial, or treatment with any investigational drug/medical device within 30 days prior to Visit 1 (Screening) or within five half-lives of an investigational drug, whichever is longer and during the entire investigation
- Midface volume deficit due to a congenital defect, trauma, or abnormalities in facial adipose tissue distribution such as those associated with HIV related lipodystrophy
- Subjects who experienced weight change for a minimum of 10% over the last 12 months (e.g., post bariatric patients), or subjects who have the intention to change eating habits that result in a weight gain or loss >10% during the entire investigation
- Any individual whose willingness to volunteer in this clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants).
- Close affiliation with the investigator (e.g., a close relative, financially dependent on the study site) or subject who is an employee of the sponsor's company or group companies of the sponsor.
- Occurrence of a related Serious Adverse Event or Adverse Event of Special Interest (i.e., embolic events, with possible, probable, or causal relationship to an intravascular injection of the device, as changes in vision [loss of vision, blurriness, double vision, pain in or around the eye, blindness, blind spots, problems moving the eyes], skin changing color around the eyelids or around the site of injection, other embolic phenomenon, e.g., stroke, skin necrosis, or impending necrosis) during or after the previous injections
- Subjects who experienced visual changes considered abnormal clinically significant or other serious medical conditions during or after the previous injections
- Subjects who have one of the following assessments during the visual examinations: Snellen acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test.
- Occurrence of a related Serious Adverse Event or Adverse Event of Special Interest (i.e., embolic events with possible, probable, or causal relationship to an intravascular injection of the device, as changes in vision [loss of vision, blurriness, double vision, pain in or around the eye, blindness, blind spots, problems moving the eyes], skin changing color around the eyelids or around the site of injection, other embolic phenomenon, e.g., stroke, skin necrosis, or impending necrosis) during or after the baseline injection and/or touch-up injections
- Occurrence of a related Adverse Event that occurred during the initial treatment phase, and is ongoing at the time of the repeat treatment (i.e., relationship is classified as "possible", "probable" or "causal relationship"; outcome is "not recovered / resolved", "recovering / resolving", "recovered / resolved with sequelae" or "unknown")
- Subjects who experienced visual changes considered abnormal clinically significant or other serious medical conditions during or after the baseline or touch-up injections, respectively
- Subjects who have one of the following assessments during the visual examinations: Snellen acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test
- Subjects who became pregnant since start of the study or planning to become pregnant during the clinical investigation
- Known human immune deficiency virus-positive individuals
- Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area
- Development of re-current (three times a year over the last year) herpes simplex in the treatment area since study start
- Development of any autoimmune or connective tissue disease since study start, or current treatment with immuno-modulating therapy
- Development of uncontrolled (or unstable) diabetes mellitus or systemic diseases since study start as per investigator discretion
- Facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) and semi-permanent fillers (e.g., poly-L-lactic acid) in the area of device application and during the initial treatment phase of the investigation
- Implantation of dermal fillers (other than the test and comparator device used in the investigation) in the treatment area during the initial treatment phase of the investigation
- Subject has received any of the following aesthetic treatments in the midface area: e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion, mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet in the outer eye region), or chemical peeling during the initial treatment phase of the investigation or is planning to undergo such procedures during the repeat-treatment phase of the investigation
- Facial lipolysis, including submental fat treatments during the initial treatment phase of the investigation
- Bariatric surgery during the initial treatment phase of the investigation
- Development of bleeding disorder and/or use of anticoagulant, antiplatelet, thrombolytic medication, or anti-inflammatory drugs (oral/injectable corticosteroids or non steroidal anti-inflammatory drugs, e.g., Motrin® or Advil®) or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., St. John's Wort, high doses of vitamin E supplements) from ten days pre- to seven days post injection (repeat-treatment and touch-up treatment)
- Planned dental/oral surgery or modification (bridge work, implants) within four weeks prior to the injection and to a minimum of four weeks post injection
- Any medical condition prohibiting the inclusion for repeat-treatment according to the judgement of the treating investigator
- Beard longer than three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator
- Previous enrollment in initial treatment phase of this clinical investigation and early termination, or significant incompliance with the protocol requirements
- Current or previous treatment with another investigational drug and/or medical device or participation in another clinical study
- Midface volume deficit due to a trauma, or abnormalities in facial adipose tissue distribution such as those associated with HIV related lipodystrophy
- Subjects who experienced weight change for a minimum of 10% since study start or subjects who have the intention to change eating habits that result in a weight gain or loss >10% during the entire investigation
- Subjects with active COVID-19 infection and subjects with symptoms consistent with COVID-19 infection including any other respiratory symptoms/illnesses within the past 14 days unless tested negative prior to Visit RT1
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
DermResearch Inc. Austin
Austin, Texas, 78759
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Aesthetic Solutions
Chapel Hill, North Carolina, 27517
Chicago Cosmetic
Chicago, Illinois, 60654
Skin Associates of South Florida
Coral Gables, Florida, 33146
Clinical Testing of Beverly Hills
Encino, California, 91436
Center for Dermatology Cosmetic & Laser Surgery
Fremont, California, 94538
About Skin
Greenwood Village, Colorado, 80111
Imagedermatology PC
Montclair, New Jersey, 07042
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Luxurgery
New York, New York, 10021
Skin Specialists
Omaha, Nebraska, 68144
Cosmetic Laser Dermatology
San Diego, California, 92121
Meridian Clinical Research, Georgia Plastic Surgery
Savannah, Georgia, 31406
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255
DermResearchCenter of NY
Stony Brook, New York, 11790
About this study
Official title: A Randomized, Subject- and Evaluator-blinded, Controlled, Non-inferiority Multicenter, Parallel Group Comparison Study to Evaluate Effectiveness and Safety of Saypha® VOLUME Lidocaine for Midface Augmentation to Correct Volume Deficit
The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC).
Read the detailed description
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study took place in the US at 16 sites.
The purpose of the current clinical investigation is to evaluate the effectiveness, safety and long-term safety of saypha® VOLUME Lidocaine for the correction of age-related moderate to severe volume deficit in the midface (augmentation of midface volume deficit), and to demonstrate its non-inferiority to one of the devices approved for the same indication (Juvéderm® Voluma™ XC). In addition, the duration of the aesthetic effect after implantation will be studied.
Approximately 486 subjects in total will be randomized and treated resulting in 437 evaluable subjects for the primary endpoint. Randomization will be in a 2:1 ratio (test device: 324, comparator device: 162).
Each subject will take part in the investigation for up to 92 weeks. The total anticipated duration of the investigation, from the first-subject-first visit to the last-subject-last-visit, is around 114 weeks, based on expected recruitment period of about 22 weeks.
- Being tested
- saypha® VOLUME Lidocaine, Juvéderm® Voluma™ XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saypha® VOLUME LidocaineCombination product
Crosslinked hyaluronic acid (HA) 23 mg/mL + 0.3% lidocaine hydrochloride.
Juvéderm® Voluma™ XCCombination product
Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| saypha® VOLUME Lidocaine | Experimental | For injection, either a needle (27G ½'') or cannula (25G 1½") may be used. Randomization will be stratified by injection equipment in a 1:1 ratio.
The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year. Receives: Combination Product: saypha® VOLUME Lidocaine |
| Juvéderm® Voluma™ XC | Active comparator | For injection, either a needle (27G ½'') or cannula (25G 1½") may be used. Randomization will be stratified by injection equipment in a 1:1 ratio.
The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year. Receives: Combination Product: Juvéderm® Voluma™ XC |
| saypha® VOLUME Lidocaine - Open Label Extension | Experimental | All participants who complete Arms 1 and 2 may optionally enroll and receive the experimental treatment. Receives: Combination Product: saypha® VOLUME Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an >=1 point improvement in MVDSS at Week 24 relative to baseline.
Measured: Week 24
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an >=1 point improvement in MVDSS at Week 24 relative to baseline. Subjects with missing baseline MVDSS score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were imputed as non-responders.
Measured: Week 24
Secondary outcomes (11)
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 36, and 48 after last injection of initial treatment compared to the score at Baseline. Subjects are defined as responders if they are showing an >=1 point improvement in MVDSS at the respective visit relative to baseline.
Measured: Weeks 4, 8, 16, 36, and 48
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the independent blinded photographic reviewer´s assessment by using photographs at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. The median of all assessments for the same photograph were taken into account.
Measured: Weeks 4, 8, 16, 24, 36, and 48
Mean Change in Midface Volume Deficit
Mean change in midface volume deficit measured on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), and based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline.
Measured: Weeks 4, 8, 16, 24, 36, and 48
Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement
Mean change in midface volume deficit as measured by volumetric change measurement by using 3D digital photographic images at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to Baseline.
Measured: Weeks 4, 8, 16, 24, 36, and 48
Change in Nasolabial Folds Measurements
Shift from baseline in nasolabial folds measured by the 5-point validated NLF-SRS (Nasolabial Folds Severity Rating Scale, where 0 means no NLF and 4 means Extreme Nasolabial fold) based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment.
Measured: Weeks 4, 8, 16, 24, 36, and 48
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the blinded evaluator's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The blinded evaluators assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved".
Measured: Weeks 4, 8, 16, 24, 36, and 48
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the subject's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The subjects assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved".
Measured: Weeks 4, 8, 16, 24, 36, and 48
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
The extent of subject's satisfaction with overall treatment outcome at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the subject using the Face-Q(TM) Questionnaire "Satisfaction with Outcome". This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1="Definitely disagree", 2="Somewhat disagree", 3="Somewhat agree", 4="Definitely agree". The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction.
Measured: Weeks 4, 8, 16, 24, 36, and 48
Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects
The extent of subject's appearance appraisal at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the FACE-Q(TM) questionnaire "Satisfaction with Cheeks" compared to Baseline visit (i.e., change from baseline). This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1="Very Dissatisfied", 2="Somewhat Dissatisfied", 3="Somewhat Satisfied", 4="Very Satisfied". The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction.
Measured: Weeks 4, 8, 16, 24, 36, and 48
Pain Assessment by Subjects
Assessment of pain associated with the procedure by subjects immediately after injection and about 15, 30, 45 and 60 minutes thereafter for initial treatment at baseline and for touch-up treatment at week 2 (if applicable). Subjects quantified the pain associated with the procedure using a semi-quantitative 11-point Numeric Pain Rating Scale (NPRS): 0 is no pain and 10 is the worst pain you can imagine. Left and right side of the face was assessed separately.
Measured: Baseline - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment; Week 2 - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment
Evaluation of Injection Volume
Injection volume required to achieve optimal aesthetic result at each treatment (baseline and touch-up treatment together) measured in mL.
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start16 Aug 2022
- Primary completion4 Oct 2023
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Midface Volume DeficitStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croma-Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elyse S Rafal, MD, Principal investigator, DermResearchCenter of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386030
- Sponsor's protocol ID
- CPH-301-201417
- Acronym
- VOLIDO
- Status last verified
- Aug 2024
- First submitted
- 11 May 2021
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No