Ptosis of the Neck, Mid-face and/or JowlNCT01100190
A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
A study testing NUVANCE Facial Rejuvenation System in people with Ptosis of the Neck, Mid-face and/or Jowl, run by Ethicon, Inc. at 9 sites in 4 countries.
Trial summary
The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ptosis of the Neck, Mid-face and/or Jowl
- What is being tested?
- NUVANCE Facial Rejuvenation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 1 Mar 2010to 1 Mar 2014
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject older than 18 years.
- Subject is a candidate for minimally invasive, bilateral facial rejuvenation procedure using NUVANCETM Facial Rejuvenation System according to the device Instructions for Use (IFU).
- Subject is willing and able to provide informed consent and follow study-related requirements.
Who cannot join
- Subject who previously received surgical facial cosmetic treatment (procedure involving an incision):
- Within the last 12 months under the area of the forehead;
- Within the last 3 months within the area of the forehead where forehead is defined as the area above the imaginary anatomical line between the lateral canthus of the eye and the upper pole of the ear.
- Subject who previously received a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within the last 9 months.
- Subjects with a permanent facial implant.
- Subjects planning on a cosmetic procedure with a permanent implant within 6-months of procedure.
Show all 13Show fewer
- Subjects planning on a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within 6-months of procedure.
- Subjects with significant ptosis where skin excision would be necessary.
- Subject has an active infection (e.g. acne, herpes zoster) or inflammation (e.g. psoriasis, pemphigus vulgaris, cutaneous lupus erythematosus) affecting facial skin.
- Subject has a history of a disorder that can affect wound healing (e.g. subjects pre-disposed to infection or history of keloid formation).
- Subject with pre-existing facial abnormalities (e.g. deformities, Bell's palsy, scarring)
- Subject with a significant psychiatric disorder judged by the clinical investigator that will interfere with the procedure
- Any pre-operative findings that the surgeon identifies that makes the subject not a candidate for a minimally invasive facial cosmetic surgical procedure.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
France3 sites
Bernard Mole
Paris, 75007
Catherine Bergeret-Galley
Paris, 75008
Benjamin Ascher
Paris, 75116
Germany3 sites
Martin-Luther-Krankenhaus
Berlin, D-14193
Chirurgie Praxisklinik Kaiserplatz
Frankfurt, 60311
Rotes Kreuz Krankenhous Kassel
Kassel, 34121
Israel2 sites
Rambam Medical Center
Haifa, 31096
Rabin Medical Center
Petah Tikva, 49100
About this study
The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.
Read the detailed description
This is a multicenter, prospective, single-arm study. The primary tolerability endpoint will be evaluated up to 30-days post-operatively. Secondary endpoints will be evaluated at 6-months. Extended follow-up will be conducted at 12-months, 24-months, and 36-months.
- Conditions
- Ptosis of the Neck, Mid-face and/or Jowl
- Being tested
- NUVANCE Facial Rejuvenation System
- Keywords
- Facelift, Rhytidectomy, Ptosis
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUVANCE Facial Rejuvenation SystemDevice
The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.
| Study group | Role | What they receive |
|---|---|---|
| NUVANCE Facial Rejuvenation System | Experimental | Not described Receives: Device: NUVANCE Facial Rejuvenation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of adverse device events
The primary tolerability endpoint includes sensory nerve injury, skin necrosis, wound dehiscence, hypertrophic scarring, alopecia, surgical site infection, earlobe deformity, submental irregularity, hematomas, perforation, and palpability.
Measured: up to 30-days post-procedure
Secondary outcomes (4)
Individual incidence of adverse device events
Measured: up to 3 yrs post-op
Incidence of treatment failures and cosmetic re-intervention
Measured: up to 3 yrs post-op
Quality of Life changes prior to and after surgery
Measured: up to 3 yrs post-op
Global Improvement Assessment using standardized photographic images
Measured: up to 3 yrs post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study start1 Mar 2010
- Primary completion1 Apr 2011
- Study completion1 Mar 2014
Why it stopped: Change in business priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ptosis of the Neck, Mid-face and/or JowlStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Weisberg, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100190
- Sponsor's protocol ID
- 200-08-001
- Status last verified
- Aug 2017
- First submitted
- 7 Apr 2010
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not an applicable trial, product manufactured outside of US and all study sites outside US.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures
- ClinicalTrials.gov ID
- NCT01100190
- Acronym / sponsor ID
- 200-08-001
- Conditions
- Ptosis of the Neck, Mid-face and/or Jowl
- Keywords
- Facelift, Rhytidectomy, Ptosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in business priorities.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 1 Apr 2011 (actual)
- Study completion
- 1 Mar 2014 (actual)
- First posted
- 8 Apr 2010 (estimated)
- 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.
The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.
Detailed description
This is a multicenter, prospective, single-arm study. The primary tolerability endpoint will be evaluated up to 30-days post-operatively. Secondary endpoints will be evaluated at 6-months. Extended follow-up will be conducted at 12-months, 24-months, and 36-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NUVANCE Facial Rejuvenation System | Experimental | Device: NUVANCE Facial Rejuvenation System |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subject older than 18 years.
- Subject is a candidate for minimally invasive, bilateral facial rejuvenation procedure using NUVANCETM Facial Rejuvenation System according to the device Instructions for Use (IFU).
- Subject is willing and able to provide informed consent and follow study-related requirements.
Key exclusion criteria (13 listed)
- Subject who previously received surgical facial cosmetic treatment (procedure involving an incision):
- Subject who previously received a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within the last 9 months.
- Subjects with a permanent facial implant.
- Subjects planning on a cosmetic procedure with a permanent implant within 6-months of procedure.
- Subjects planning on a cosmetic procedure with a dermal filler device and/or neurotoxin complex injectable within 6-months of procedure.
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 |
|---|---|---|
| NUVANCE Facial Rejuvenation SystemThe NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator. | Device | NUVANCE Facial Rejuvenation System |
Primary outcome
Composite incidence of adverse device events
Time frame: up to 30-days post-procedure
The primary tolerability endpoint includes sensory nerve injury, skin necrosis, wound dehiscence, hypertrophic scarring, alopecia, surgical site infection, earlobe deformity, submental irregularity, hematomas, perforation, and palpability.
4 secondary outcomes
Individual incidence of adverse device events
Time frame: up to 3 yrs post-op
Incidence of treatment failures and cosmetic re-intervention
Time frame: up to 3 yrs post-op
Quality of Life changes prior to and after surgery
Time frame: up to 3 yrs post-op
Global Improvement Assessment using standardized photographic images
Time frame: up to 3 yrs post-op
Results and safety
The study was stopped early (reason given: Change in business priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: No. Not an applicable trial, product manufactured outside of US and all study sites outside US.
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.
Martin Weisberg, MD study director
Ethicon, Inc.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUVANCE Facial Rejuvenation System in people with Ptosis of the Neck, Mid-face and/or Jowl, run by Ethicon, Inc. at 9 sites in 4 countries.
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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Germany, Israel, United Kingdom. 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 was stopped early (reason given: Change in business priorities.). Results are not available in the source record.
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?
Composite incidence of adverse device events (time frame: up to 30-days post-procedure). 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 11 Aug 2017.