NCT01197547已完成不适用
Genesys HTA Post Approval Registry A Multi-center, Single-arm, Prospective Registry of the Genesys HTA System for the Treatment of Menorrhagia
Minerva Surgical, Inc.19 个研究点 分布在 1 个国家目标入组 1,014 人开始时间: 2010年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,014
- 试验地点
- 19
- 主要终点
- Burn Rate
研究概览
简要总结
This is a clinical registry of an FDA approved device system called the Genesys Hydro ThermAblatorTM (HTA) system (Boston Scientific). The HTA system's intended use is to be inserted, by a trained physician, into the uterus, where it will fill and circulate fluid that is warm enough to change the characteristics of the uterine lining. This is done with the anticipated result of improving menstrual bleeding symptoms.
The purpose of this FDA-mandated registry is to obtain clinical experience on the use the Genesys HTA™ system, under normal clinical conditions, and document its safety and technical reliability.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject must meet the approved indication for use to be considered for this registry.
排除标准
- •All subjects contraindicated for the treatment of the Genesys HTA System per the Directions for Use will be excluded:
- •The subject is pregnant or wants to be pregnant in the future
- •The subject has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia
- •The subject has active pelvic inflammatory disease or pyosalpinx
- •The subject has hydrosalpinx
- •The subject in whom a tight cervical seal cannot be established and maintained around the procedure sheath
- •The subject has an anatomical condition (e.g. history of previous classical cesarean section or transmural myomectomy) or pathologic condition (e.g. long term medical therapy) that could lead to weakening of the myometrium
- •The subject has an intrauterine device in place
- •The subject has an active genital or urinary tract infection (e.g. cervicitis, endometritis, vaginitis, cystitis, etc.) at the time of treatment
研究组 & 干预措施
Genesys HTA
Other
Genesys HTA Endometrial Ablation
干预措施: Genesys HTA (Device)
结局指标
主要结局
Burn Rate
时间窗: Day 1
次要结局
- Technical Malfunctions(Day 1)
- Serious Adverse Device Effect (SADE)(Day 1)
研究者
研究点 (19)
Loading locations...
相似试验
进行中（未招募）
不适用
Destination Therapy Post Approval StudyChronic Heart FailureNCT03681210Medtronic Cardiac Rhythm and Heart Failure300
已完成
不适用
HTRS TE Registry (ThromboEmbolism Registry)ThromboembolismNCT00266994Nationwide Children's Hospital2,760
招募中
不适用
Aeson TAH System - Post-Market Clinical Follow-up StudyHeart FailureNCT05474092Carmat SAS95
已完成
不适用
CryoSpray Ablation (TM) GI Patient RegistryBarrett's EsophagusEsophageal CancerNCT00747448CSA Medical, Inc.199
已完成
不适用
Zenith TX2® Post-market Approval StudyDescending Thoracic Aortic AneurysmNCT00813358Cook Research Incorporated115