Please assess the completion status of the following clinical trial:

Trial Title: Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: None
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~1. Male or female subjects 35-65 years of age (inclusive).~2. Healthy as determined by the investigator examining the subject.~3. Seeking improvement of the appearance of lax tissue in the neck and submental region.~4. Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.~5. Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.~6. Willing to release rights for the use of study photos, including in potential publication.~7. Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study.~8. Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure.~9. Willing to abstain from smoking, vaping, or the use of e-cigarettes for 1 year prior to and for the entire duration of participation in the study.~10. Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study.~11. Able to read, understand, sign and date the informed consent document (English only).~Exclusion Criteria:~1. Pregnant or lactating.~2. Pregnancy within 12 months prior to screening.~3. Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia).~4. Allergy to tumescent anesthetic (lidocaine/epinephrine).~5. Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).~6. Active systemic or local skin disease that may alter wound healing.~7. Significant or uncontrolled medical condition that, in the opinion of the investigator, participation in the study may compromise the patient's health.~8. Severe solar elastosis.~9. History of autoimmune disease (excluding Hashimoto's thyroiditis).~10. Known hypersensitivity or adverse reaction to anesthetics.~11. Known susceptibility to keloid formation or hypertrophic scarring.~12. Cancerous or pre-cancerous lesions in the area to be treated.~13. History or current diagnosis of cancer of any type (excluding skin cancer).~14. History of uncontrolled cardiovascular disease (i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other).~15. History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants.~16. Possesses a surgically implanted electronic device (i.e. pacemaker).~17. History of AIDs/HIV.~18. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.~19. Chronic hypoxia or dependence on supplemental oxygen.~20. Participation in any other investigational study within 30 days prior to consent.~21. Any surgical or transdermal neck/submental aesthetic procedures or plans to undergo any other aesthetic procedure during study participation. Such procedures include, but are not limited to, submentoplasty, liposuction, ultrasound, cryolipolysis, radiofrequency, and laser.~22. History of or current injury to the head and neck or any area of the body being treated as a part of this study.~23. Presence of more than mild platysmal banding as per the Geister, et al Validated Assessment Scale for Platysmal Bands.~24. Subject requiring removal of adipose tissue prior index procedure.~25. A family member of the investigator or sponsor; an employee of the investigator or sponsor.~26. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

- Gender: ALL
- Minimum Age: 35 Years
- Maximum Age: 65 Years
- Healthy Volunteers: t

Study Arms:
- Study Phase I (Type: EXPERIMENTAL): Subjects will be treated with the Renuvion APR device in the neck and submental region.
- Study Phase II (Type: EXPERIMENTAL): Subjects will be treated with the Renuvion APR device in the neck and submental region.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete