Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Device malfunctions
研究概览
简要总结
The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patient is a pregnant woman 18 and older
- •The mother must be healthy enough to have surgery
- •The mother must be scheduled for surgery
- •Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
排除标准
- •Age <18 years
- •Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- •Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
- •Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival.
研究组 & 干预措施
Karl Storz fetoscopes
Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy.
干预措施: Karl Storz New Generation Fetoscope - curved 11508AAK (Device)
Karl Storz fetoscopes
Participants will receive In utero surgery using the new generation Karl Storz fetoscopes (11508AAK and 11506AAK) for fetal conditions amenable to treatment with fetoscopy.
干预措施: Karl Storz New Generation Fetoscope - straight 11506AAK (Device)
结局指标
主要结局
Device malfunctions
时间窗: 12 months
The number of device malfunction incidents
Adverse events
时间窗: 12 months
The count of subjects who experience adverse events
Serious Adverse Events
时间窗: 12 months
The count of subjects who experience serious adverse events
次要结局
- Mean gestational age at delivery(12 months)
- Successful Completion(12 months)
- Satisfaction scores(12 months)
- Live births(12 months)
- Neonatal deaths(12 months)
研究者
Mauro H. Schenone
Principal Investigator
Mayo Clinic