NCT01993238已完成不适用
An Evaluation of Procedural Analgesia for Out-Patient Liposonix Treatment
Solta Medical1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pain Score for Overall Treatment
研究概览
简要总结
The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an adult female or male, 18 to 65 years of age.
- •Subject must weigh more than 120 pounds.
- •Subject must have a Body Mass Index of ≤ 30 kg/m
- •Subject must have thickness of skin + subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm.
- •Subject must be able to read, write, speak, and understand English.
排除标准
- •Female subject who is pregnant, is suspected to be pregnant, or is lactating
- •Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
- •Subject has diabetes or cardiovascular disease
- •Subject has had any aesthetic procedure to the region to be treated within past 6 months
- •Subject has systemic skin disease or skin disease in the area to be treated
- •Subject has any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated
- •Subject has had previous open or laparoscopic surgery in the anticipated treatment area
- •Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
- •Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position
- •Subjects undergoing chronic steroid or immunosuppressive therapy
- •Subjects who have cardiac pacemakers or any implantable electrical device
- •Subjects who have metal implants of any type in the area to be treated
- •History of cancer
- •Subjects who have sensory loss or dysesthesia in the area to be treated
- •Subjects taking chronic benzodiazepines or opiates
- •Subjects with a history of severe nausea/vomiting with opioid analgesics
- •Subjects with sleep apnea
- •Subjects with known allergies or sensitivities to study drugs
- •Subjects with liver disease
- •Subjects with renal failure
研究组 & 干预措施
Liposonix with pre-treatment analgesia
Experimental
Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
干预措施: Liposonix System (Model 2) (Device)
Liposonix with pre-treatment analgesia
Experimental
Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
干预措施: Pre-treatment analgesia (Drug)
结局指标
主要结局
Pain Score for Overall Treatment
时间窗: Baseline
Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)
次要结局
- Safety Assessment(Baseline, 1 day, 1 week)
- Pain Scores Reported at 1-day Post-Treatment(1 day)
研究者
研究点 (1)
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