NCT07802431Toboroz
Clinical Evaluation of Linear Z for Body Contouring
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2026. aug. 27.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2026. dec. 20.
- Fő szponzor
- Jeisys Medical Inc
- NCT-szám
- NCT07802431
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 30
- 2026. szept. 1. és az elsődleges befejezés (2026. dec. 20.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálatot írja le, nem a te helyzetedet.
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Korábbi kezelés
- Previous body contouring procedures in the treatment area within the past 6 months.
- Use of anticoagulant therapy.
- Participation in another clinical investigation within the previous 30 days.
- Metal implants in the treatment area.
- 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.
Más betegség
- Active dermatologic conditions or infections.
- Coagulation disorders.
- Severe uncontrolled systemic disease.
- Active malignancy.
- History of keloid formation or poor wound healing.
- Psychiatric conditions that affect the ability to provide informed consent or that affect body-image perception.
Egyéb
- Pregnancy or breastfeeding.
- Women planning pregnancy during study participation.
- 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.
- Implanted electronic devices, such as a pacemaker or implanted defibrillator.
- Any contraindication listed in the device manual.
- Hernia in the treatment area.
- Significant open scars, tattoos, or wounds in the treatment area.
- Altered sensation or neuropathy.
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Especialistas de la Piel y Cirugía, S.C. Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Nuevo León | Mexikó | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.