Dermal Cryotherapy in Patients Undergoing Abdominoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-04-30

Brief Summary

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A prospective, interventional, single-arm study to evaluate histologic changes in skin following cryotherapy with the study device.

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Detailed Description

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This study is to include healthy adults who intend to undergo an abdominoplasty surgery, and agree to have small areas of their middle and lower abdomen exposed to cooling with the Dermal Cooling System within 180 days before the planned surgery. Exposure of multiple test sites will be completed in areas of skin that will be excised as part of the abdominoplasty procedure. Clinical assessments of the treatment sites at 1-week post-treatment and at 1-month post-treatment intervals throughout the time period prior to surgical excision, and histologic evaluation of the treated skin will be conducted to assess skin changes.

Conditions

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Skin Laxity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with cryotherapy

Treatment with dermal cooling system.

Group Type EXPERIMENTAL

Dermal Cooling System

Intervention Type DEVICE

Treatment with dermal cooling system.

Interventions

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Dermal Cooling System

Treatment with dermal cooling system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects \> 18 years of age.
2. Subjects eligible, consented, and scheduled for abdominoplasty.
3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
4. Subject has read and signed a written informed consent form. -

Exclusion Criteria

1. Subject has medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., liposuction, mesotherapy, hydroquinone, corticosteroids, laser surgery).
2. Subject has a known history of subcutaneous injections into the abdomen within the past six months (e.g., insulin, Enbrel).
3. Subject has a known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease).
4. Subject is taking methylxanthines (phosphodiesterase-inhibitors like amino- or theophylline)
5. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period.
6. Subject is unable or unwilling to comply with the study requirements.
7. Subject has any dermatological conditions or scars (other than stretch marks) within the area of planned abdominoplasty excision that may interfere with the ability to obtain test sites for treatment or evaluation.
8. Subject has a history of abnormal wound healing or abnormal scarring.
9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
10. Patient is pregnant or intending to become pregnant within the next 6 months.
11. Patient is lactating or has been lactating in the past 9 months.
12. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the patient.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes