A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of completed fetoscopic procedures
研究概览
简要总结
In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.
详细描述
The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants who undergo intrauterine procedures with these devices. The scopes will be used to assist in intrauterine procedures across a variety of fetal conditions, such as TTTS (twin-twin transfusion syndrome), TAPS (twin anemia polycythemia sequence), sFGR (selective fetal growth restriction) or TRAP sequence (twin reversed arterial perfusion). Fetoscopic laser photocoagulation (FLP) can also be used during in-utero surgery to correct abnormal vessels in cases like chorioangioma or vasa previa. Other complex congenital anomalies may require fetal intervention or diagnostic fetoscopy using Storz scopes.
Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery. Smaller fetoscopes are associated with lower rates of premature delivery following FLP. New fetoscopes (11508AAK and 11506AAK) have the potential to improve visualization and the photocoagulation angle. Compared to alternative scopes, these Storz scopes provide a wider angle of view and are longer, enabling better reach to distant areas at the edge of the placenta, especially in cases of higher BMI, higher gestational age, and significant polyhydramnios.
This study is an un-blinded, non-randomized, single arm, feasibility study on a convenience cohort to demonstrate the role of a curved fetoscope device (11508AAK) or straight fetoscope device (11506AAK) among in-utero surgeries. Patients will be enrolled in a consecutive manner and all qualifying, patients who agreed to the use of the curved or straight fetoscopes will be enrolled in the study. Outcome data will be reported as a descriptive statistical analysis. The curved fetoscope (11508AAK) device will be used in monochorionic pregnancies with an anterior placenta requiring in-utero surgery, while the straight fetoscope (11506AAK) will be used in monochorionic pregnancies with a posterior placenta. This device is classified as a significant risk device because it is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patient with a condition requiring in-utero surgery
- •Patient must be eligible for anesthesia
- •Patient and father of the fetus (if available) are able to provide signed informed consent
排除标准
- •Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
- •Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
- •Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
- •Pre-pregnancy maternal BMI greater than 40
- •High risk for fetal hemophilia
- •Fetal aneuploidy or variants of known significance if an amniocentesis was performed
- •Contraindication to abdominal surgery or fetoscopic surgery
结局指标
主要结局
Rate of completed fetoscopic procedures
时间窗: 3 years from study start date
The rate of successfully completed intrauterine procedures (out of 50 total) using the Karl Storz Curved (11508AAK) or Straight (11506AAk) Fetoscope will be measured.
Fetal survival at birth
时间窗: When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.
The number of fetuses who undergo an intrauterine fetoscopic procedure using these devices and survive at birth will be analyzed.
次要结局
- The rate of preterm labor(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- Successful coagulation of all targeted vessels(3 years from study start date)
- The rate of iatrogenic septostomy(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- Rate of TAPS(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- The rate of preterm premature rupture of membranes (PPROM)(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- The rate of choriamniotic separation (CAS)(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- Recurrence of TTTS(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- Successful visualization of all targeted vessels(3 years from study start date)
- The rate of completed Solomonizations(3 years from study start date)
- Fetal survival 48 hours post-procedure(24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.)
- Gestational age at delivery(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- Time from procedure to delivery(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- Length of procedure(3 years from study start date)
- The rate of placental abruption(When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.)
- The rate of any perioperative complications (within 24 hours post-procedure)(24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.)
- Neonatal survival 30 days after birth(When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.)
- Short term need for ECMO(When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.)
- Short term morbidity(When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.)
研究者
Eyal Krispin
Attending Physician, Maternal Fetal Care Center
Boston Children's Hospital