WithdrawnNot Applicable

Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study

Stopped: Per Investigator and sponsor decision

United States0Started 2019-10-23

Plain-language summary

Prospective, Open-Label, Single-Center Pilot Study. The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin. The study will include up to 2 subjects. Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Subject seeking surgical correction of abdominal tissue laxity with an abdominoplasty within the subsequent 1-12 months.
✓. Subject abdominal skin must be of appropriate quality to allow for proper study treatment, as judged by the Investigator.
✓. The subject must be willing to have punch biopsy specimens obtained from all treated areas following treatment.
✓. The Subject must sign a statement of informed consent to the Investigator and Sponsor.

Exclusion criteria

✕. The subject is less than 18 or greater than 75 years of age.
✕. Subject with excessive superficial skin laxity and/or striae of the abdomen, which would prevent proper study treatment.
✕. A subject that is unwilling to have punch biopsy specimens obtained from treated areas.
✕. Subject with a history of allergy to lidocaine or epinephrine.
✕. Known history of keloids or bleeding/coagulation disorder.
✕. Presence of surgical or non-surgical scars in the area to be treated.
✕. Active inflammatory or infectious process or any other active or serious skin disease in the area to be treated.
✕. Planned surgical procedures with incisions and suturing in the area to be treated during the course of the study.

What they're measuring

Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters

Timeframe: Immediately post treatment

Trial details

NCT IDNCT04153071

SponsorAlma Lasers

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-09-16

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