AbdominoplastyeMatrixCO2NCT01026662
In-vivo Analysis of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue
An observational study of Abdominoplasty, run by Syneron Medical at 1 site in United States.
Trial summary
This study will: Evaluate the in vivo effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- Ablation and skin resurfacing and eMatrixCO2
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Apr 2010
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Subjects scheduled for an abdominoplasty surgery
Who may be able to join
- Informed consent agreement signed by the subject.
- Healthy males or females older than 21 to 60 years of age.
- Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I - V).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Who cannot join
- Pregnant and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes
- Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
- Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
Show all 22Show fewer
- Having received collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study.
- Having received Botox in the treated area within 6 months of treatment or during the study.
- Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
- History of keloid scarring or of abnormal wound healing.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- Suffering from hormonal imbalance, as per the Investigator's discretion.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including actinic keratosis, presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
- Vascular lesion, tattoo or permanent make-up in the treated area.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Participation in a study of another device or drug within three month prior to enrollment or during the study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
SouthWestern Medical Center
Dallas, Texas, 75390-8843
About this study
This study will:
Evaluate the in vivo effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment.
- Conditions
- Abdominoplasty
- Being tested
- Ablation and skin resurfacing, eMatrixCO2
- Keywords
- Aesthetic dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation and skin resurfacingProcedure or surgery
Subjects will receive treatment on the abdomen at different timepoints prior to a scheduled abdominoplasty. Following tissues excision samples of the treated tissue will be taken for analysis.
eMatrixCO2Device
| Study group | Role | What they receive |
|---|---|---|
| Abdominoplasty | Subjects scheduled for abdominoplasty surgery Receives: Procedure: Ablation and skin resurfacing; Device: eMatrixCO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points
Measured: Immediate, 1, 3, 10, 30 days
Record number and type of any AE during the study
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026662
- Sponsor's protocol ID
- eMatrixCO2 Preab
- Acronym
- eMatrixCO2
- Status last verified
- Nov 2014
- First submitted
- 3 Dec 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vivo Analysis of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue
- ClinicalTrials.gov ID
- NCT01026662
- Acronym / sponsor ID
- eMatrixCO2 / eMatrixCO2 Preab
- Conditions
- Abdominoplasty
- Keywords
- Aesthetic dermatology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- First posted
- 4 Dec 2009 (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.
This study will:
Evaluate the in vivo effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominoplasty | – | Procedure: Ablation and skin resurfacing, Device: eMatrixCO2Subjects scheduled for abdominoplasty surgery |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Subjects scheduled for an abdominoplasty surgery
Key inclusion criteria (5 listed)
- Informed consent agreement signed by the subject.
- Healthy males or females older than 21 to 60 years of age.
- Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I - V).
- Willingness to follow the treatment and follow-up schedule and the post-treatment care.
- For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
Key exclusion criteria (22 listed)
- Pregnant and/or breastfeeding.
- Having a history of diseases stimulated by heat, such as recurrent Herpes
- Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
- Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
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 |
|---|---|---|
| Ablation and skin resurfacingSubjects will receive treatment on the abdomen at different timepoints prior to a scheduled abdominoplasty. Following tissues excision samples of the treated tissue will be taken for analysis. | Procedure or surgery | Abdominoplasty |
| eMatrixCO2 | Device | Abdominoplasty |
Primary outcome
Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points
Time frame: Immediate, 1, 3, 10, 30 days
Record number and type of any AE during the study
Time frame: Throughout study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
Related trials for Abdominoplasty
Active, not recruiting
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Gynecologic Surgery
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Not yet recruitingObservational study
Gastroesophageal Reflux and Respiratory Function in Patients Undergoing Abdominoplasty
Abdominoplasty, Diaphragm
Active, not recruiting
Abdominal Rectus Diastasis (ARD) Reconstruction
Rectus Diastasis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Abdominoplasty, run by Syneron Medical 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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 2 Dec 2014. 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?
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?
Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points (time frame: Immediate, 1, 3, 10, 30 days). The study lists 2 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 2 Dec 2014.