Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue
This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment and Group B which receives sham treatment and will serve as a control to verify the treatment outcomes. Subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). All of the study subjects will receive the treatment (either active or sham) with the subject device.
At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New Jersey
-
Hackensack, New Jersey, 미국, 07601
- Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age > 21 years
- Voluntarily signed an informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study.
- Willingness to abstain from partaking in any treatments other than the study procedure
- Willingness to comply with study instructions, to return to the clinic for the required visits and to undergo punch biopsies in the abdominal area.
Exclusion Criteria:
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants in the treated area
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Injured or otherwise impaired muscles in the treated area
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations in the treated area
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Application during pregnancy, postpartum period, nursing, and menstruation
- Graves' disease
- Skin related autoimmune diseases that may contradict the biopsy
- Poor healing and unhealed wounds in the treatment area
- Any disease or condition contradicting the skin tissue biopsy
- Any disease or condition that may compromise the histologic observation at the pathologist discretion
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Histological evaluation of BTL-899 device´s effect on fat tissue
This group will be treated with 100% of the treatment parameter settings
|
BTL-899 treatment
|
|
가짜 비교기: Sham treatment
This group will be treated with 5% of the treatment parameter settings
|
BTL-899 treatment
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Increased caspase-3 activity
기간: 1 month
|
Biopsy samples of the abdominal fat tissue will be processed for histological evaluation by a certified laboratory.
Conventional staining will be used to determine the changes in the fat tissue related to the increase in caspase-3 activity, which is associated with elevated levels of fat tissue apoptosis, and to examine other morphological changes of treated tissue, in all collected samples.
Post-treatment findings will be compared to the baseline.
The results of both study groups will be compared as well.
|
1 month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety assessment
기간: 1 month
|
Occurrence of adverse events
|
1 month
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- BTL-899_CTUS400
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .