Histology Evaluation of the CO2RE Device Versus the RePair Device

• Register: ClinicalTrials.gov
• Last refreshed on: 8 June 2015
• Main ID: NCT02147756
• Date of registration: 22/05/2014
• Prospective Registration: No
• Primary sponsor: Syneron Medical
• Public title: Histology Evaluation of the CO2RE Device Versus the RePair Device
• Scientific title: In Vivo Histology Evaluation of the CO2RE Device Versus the RePair Device in Pre- Abdominoplasty Patients
• Date of first enrolment: May 2014
• Target sample size: 2
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT02147756
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Argentina

Contacts

• Name: Shlomit Mann
• Affiliation: Syneron Medical Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject is scheduled and cleared for an abdominoplasty procedure by a referring
plastic surgeon.

2. Subject has read and signed the informed consent form.

3. Subject is willing to follow the treatment and follow up schedule and undertake to
carry out all necessary precautions and instructions.

4. Female candidates must be 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).

5. Subject is willing to have photographs taken which will be used for educational and
marketing presentations and/or publications.

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago,
and/or breast feeding. To verify that subjects who are enrolled are not pregnant, a
urine pregnancy test will be performed for each women subject at baseline and again
at the end of the study.

2. Subject has any active electrical implant anywhere in the body, such as a pacemaker,
an insulin pump or an internal defibrillator.

3. Subject has a permanent implant in the treated areas, such as metal plates and screws
or an injected chemical substance.

4. Subject is or has undergone any form of treatment for active cancer in the treated
area, suffering or having a history of skin cancer or any other cancer in the treated
area, including presence of malignant or pre-malignant pigmented lesions in the
treated area.

5. Subject suffers from significant concurrent illness, such as cardiac disorders,
diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders,
hepatitis and fat metabolism disorders.

6. Subject suffers from abdominal wall hernia and is a candidate for treatment in the
abdomen.

7. Subject has undergone Bariatric surgery with significant skin laxity.

8. Subject has a history of advanced fatty liver or a known liver dysfunction.

9. Subject has a thromboembolic phenomenon, hypercoagulability, and tendency to bleed or
bruise or is 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's discretion).

10. Subject has a history of immunosuppression/immune deficiency disorders (including HIV
infection) or currently using immunosuppressive medications.

11. Subject has a history of significant lymphatic drainage problems.

12. Subject is suffering from hormonal imbalance which may affect weight, as per the
Investigator's discretion.

13. Subject is suffering from significant skin conditions in the treated areas or
inflammatory skin conditions, including, but not limited to, 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.

14. Subject has a history of epidermal or dermal disorders (particularly if involving
collagen or microvascularity), keloid scarring or of abnormal wound healing.

15. Subject received treatment with laser or other devices in the treated areas within 6
months of treatment.

16. Subject underwent a liposuction surgery or any contouring treatment in the areas
intended for treatment within 9 months of treatment.

17. Subject is recently tanned in areas to be treated.

18. Subject is participating in a study of another device or drug within 1 month prior to
enrollment or during this study.

19. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Skin Pigmentation and Texture Disorders.

Intervention(s)

Device: CO2RE

Device: Repair

Primary Outcome(s)

Histological changes in skin tissue (epidermal, dermal and subcutaneous) of the treated areas. [Time Frame: Immediately, 1 week or 4 weeks prior the scheduled abdominoplasty]

Secondary ID(s)

DHF12531

Source(s) of Monetary Support

Please refer to primary and secondary sponsors