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Clinical Evaluation of Linear Z for Body Contouring

2026년 9월 1일 업데이트: Jeisys Medical Inc

Prospective, Single-center, Single-arm Clinical Research Evaluating the Safety and Effectiveness of Linear Z for Non-invasive Body Contouring of the Abdomen and Flanks

This clinical study will evaluate the safety and effectiveness of LinearZ, a non-invasive focused ultrasound device, for body contouring of the lower abdomen and flanks.

Approximately 30 adults with localized fat in the abdomen and flanks will participate in the study. Each participant will receive one treatment with LinearZ to the lower abdomen and flanks and will be followed for approximately 90 days.

The main purpose of the study is to determine whether treatment with LinearZ reduces the circumference of the treated area 90 days after treatment. The study will also evaluate changes in body circumference at Day 30, changes in body contour and appearance, participant satisfaction, body weight, body mass index (BMI), and body composition. Standardized photographs and three-dimensional images will also be used to assess changes in the treated areas.

The safety and tolerability of the treatment will be evaluated throughout the study by monitoring adverse events and treatment-related pain or discomfort.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the safety and effectiveness of LinearZ for non-invasive body contouring of the lower abdomen and flanks.

Approximately 30 eligible adult participants with localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks will be enrolled. All eligible participants will receive a single treatment with LinearZ to the lower abdomen and bilateral flanks. There is no randomization or comparator group in this study.

LinearZ is a focused ultrasound device designed to deliver ultrasound energy at specific depths within subcutaneous tissue for non-invasive body contouring. Treatment will be performed according to predefined study procedures and sponsor-approved treatment instructions. Treatment parameters, including the treatment area, cartridge type, treatment depth, energy level, and number of treatment lines or shots, will be documented.

Participants will undergo screening and baseline assessments before treatment and will return for follow-up assessments approximately 30 and 90 days after treatment.

The primary effectiveness assessment is the change from baseline in the circumference of the treated area at Day 90. Circumference measurements will be performed using standardized procedures at predefined anatomical landmarks.

Additional effectiveness assessments include change in circumference at Day 30, aesthetic improvement, participant satisfaction, changes in body weight and body mass index (BMI), and changes in body composition. Standardized clinical photography and three-dimensional imaging will also be used to document and evaluate changes in body contour. Independent blinded evaluators will review standardized images to help minimize assessment bias.

Safety and tolerability will be evaluated throughout the study by monitoring treatment-emergent adverse events, device-related adverse events, serious adverse events, and treatment-related pain or discomfort. Immediate post-treatment skin reactions and other local responses will also be assessed.

Each participant will participate in the study for approximately 90 days from the day of treatment.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 멕시코
    • Monterrey
      • Nuevo León, Monterrey, 멕시코, 64060
        • 모병
        • Especialistas de la Piel y Cirugía, S.C.
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Adults aged 18 to 65 years.
  • Participants of either sex.
  • Body mass index (BMI) greater than 20 kg/m².
  • Presence of localized, visible, and measurable subcutaneous adiposity of the abdomen and flanks considered adequate for non-invasive body contouring by the investigator.
  • Minimum subcutaneous fat thickness of 30 mm, assessed clinically or by caliper/ultrasound.
  • Stable body weight (±3 kg) for the past 3 months.
  • Willingness to maintain stable diet and exercise habits during study participation.
  • Ability to comply with study requirements.
  • Provision of written informed consent.
  • Compliance with other clinical criteria defined for the study.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Women planning pregnancy during study participation.
  • Previous body contouring procedures in the treatment area within the past 6 months.
  • Moderate to severe skin laxity in the treatment area that, in the investigator's judgment, is likely to interfere with assessment of body-contouring results.
  • Active dermatologic conditions or infections.
  • Implanted electronic devices, such as a pacemaker or implanted defibrillator.
  • Coagulation disorders.
  • Use of anticoagulant therapy.
  • Severe uncontrolled systemic disease.
  • Participation in another clinical investigation within the previous 30 days.
  • Any contraindication listed in the device manual.
  • Hernia in the treatment area.
  • Metal implants in the treatment area.
  • Significant open scars, tattoos, or wounds in the treatment area.
  • Altered sensation or neuropathy.
  • Active malignancy.
  • History of keloid formation or poor wound healing.
  • Use of weight-loss medications or GLP-1 agonists within the previous 3 months.
  • Previous liposuction or surgery in the treatment area within the previous 12 months.
  • Psychiatric conditions that affect the ability to provide informed consent or that affect body-image perception.
  • Women of childbearing potential who are unwilling to use medically acceptable contraception during study participation.
  • Any participant who, in the investigator's opinion, is not suitable for participation or is unlikely to comply with study procedures or complete the study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: A single-arm study where subjects will receive HIFU for non invasive body contouring
Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks. Treatment will be performed according to the predefined study treatment parameters. Participants will be followed for approximately 90 days after treatment to evaluate the safety and effectiveness of the treatment.
장치: High Intensity Focused Ultrasound
Participants will receive a single treatment with the LinearZ focused ultrasound device for non-invasive body contouring of the lower abdomen and bilateral flanks. The device delivers focused ultrasound energy at specific depths within the subcutaneous tissue. Treatment will be performed according to the sponsor-approved treatment manual, site-specific operating procedures, and study procedures. All participants will receive treatment to both the lower abdomen and flanks during the treatment session and will be followed for approximately 90 days after treatment.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Circumference of the Target Area at Day 90
기간: Baseline to day 90
The change in circumference of the treated target area from baseline to Day 90 will be assessed using standardized circumference measurements. The target area includes the lower abdomen and bilateral flanks. Circumference will be measured at a predefined and documented anatomical level using a standardized procedure, and the average of three consecutive measurements will be used for analysis.
Baseline to day 90

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Circumference of the Target Area at Day 30
기간: Baseline to Day 30
Change in circumference of the treated target area from baseline to Day 30 will be assessed using standardized circumference measurements at predefined anatomical points encompassing the lower abdomen and bilateral flanks. The average of three consecutive measurements will be used for analysis.
Baseline to Day 30
Proportion of Participants Achieving ≥5 cm Reduction in Circumference at Day 90
기간: Baseline to Day 90
Percentage of participants who achieve a reduction of at least 5 cm in circumference of the treated target area compared with baseline.
Baseline to Day 90
Proportion of Participants Achieving ≥10 cm Reduction in Circumference at Day 90
기간: Baseline to day 90
Percentage of participants who achieve a reduction of at least 10 cm in circumference of the treated target area compared with baseline.
Baseline to day 90
Global Aesthetic Improvement Scale (GAIS) Score
기간: Day 30 and Day 90
Aesthetic improvement of the treated area will be assessed using the Global Aesthetic Improvement Scale (GAIS) at follow-up visits.
Day 30 and Day 90
Blinded Independent Photographic Evaluation of Aesthetic Improvement
기간: Baseline, Day 30 and Day 90
Independent blinded evaluators will assess aesthetic improvement using standardized photographs obtained at baseline and follow-up visits.
Baseline, Day 30 and Day 90
Participant Satisfaction With Treatment Outcome
기간: Day 30 and Day 90
Participant satisfaction with the treatment outcome will be assessed using the study-specified satisfaction questionnaire.
Day 30 and Day 90
Change From Baseline in Body Weight
기간: Baseline to Day 30 and Day 90
Change in participant body weight from baseline will be assessed at follow-up visits.
Baseline to Day 30 and Day 90
Change From Baseline in Body Mass Index (BMI)
기간: Baseline to Day 30 and Day 90
Change in BMI from baseline will be assessed at follow-up visits. BMI is expressed in kg/m².
Baseline to Day 30 and Day 90
Change From Baseline in Fat Mass and Fat-Free Mass
기간: Baseline to Day 30 and Day 90
Change in fat mass and fat-free mass from baseline will be assessed using the InBody body composition measurement system.
Baseline to Day 30 and Day 90
Procedural Pain and Discomfort Score Using an 11-Point Numeric Rating Scale
기간: Immediately after each treatment.
Procedural pain associated with radiofrequency treatment will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater procedural pain.
Immediately after each treatment.

기타 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment-Emergent Adverse Events
기간: From treatment through Day 90
Treatment-emergent adverse events will be monitored from the treatment procedure through the final follow-up visit. Adverse events will be assessed for severity and relationship to the study device/procedure in accordance with the study protocol.
From treatment through Day 90

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Jeisys Medical Inc

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2026년 12월 20일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 8월 27일

QC 기준을 충족하는 최초 제출

2026년 9월 1일

처음 게시됨 (실제)

2026년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • LIN-BD-01-2026

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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