Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study

NCT04153071 | Withdrawn FDA Device

• 1 other identifier: ALM-OPUS-19-010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Resurfacing

Outcome Measures

Primary Outcomes (1)

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

  Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens

  Immediately post treatment

Secondary Outcomes (1)

• Rate of adverse events

  10 days

Study Arms (1)

Unipolar microplasma RF treatment

EXPERIMENTAL

Single cutaneous unipolar microplasma RF treatment, with variable treatment parameters

Device: OPUS system

Interventions

OPUS system DEVICE

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.

Unipolar microplasma RF treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects who have used oral isotretinoin or other oral retinoids during the study in the prior 12 months or planning to be on them during the course of the study.
• Subjects receiving antiplatelet, anticoagulant, or non-steroidal anti-inflammatory agents within 2 weeks of treatment, or planning to receive during the course of the study; in whom, in the Investigator's opinion, administration of radiofrequency treatment may cause procedure-related complications.
• Women who are pregnant, nursing or intend to become pregnant over the duration of the study, or women who are of childbearing potential not protected by an effective contraceptive method of birth control. Pregnancy status should be checked by urine testing at baseline (Day 0).
• Subjects who are unwilling or unable to give written consent to participate in the study or unable to comply with the requirements of the clinical trial protocol.
• Subjects who have received an experimental drug or device within the previous 3 months prior to enrollment.
• Subjects who are known as alcohol or drug abusers.
• Subjects who are suffering from any physical or psychological condition, or are under treatment for any such condition which, in the opinion of the Investigator, may constitute an unwarranted risk or which may affect the subjects' compliance or adherence to study procedures.

Sponsors & Collaborators

• Alma Lasers: lead

Study Sites (1)

Westlake Dermatology Clinical Research Center

Austin, Texas, 78746, United States

Location

Study Officials

• Daniel Friedmann, MD, FAAD

  Westlake Dermatology Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: October 23, 2019
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: September 25, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)