Fetal Embolization for Severe Vein of Galen Malformation - A Feasibility and Safety Trial
Fetal Embolization Via Transcardiac Transarterial Ultrasound and Fluoroscopy-guided Endovascular Surgery (FETTUS) for Severe Vein of Galen Malformation - A Feasibility and Safety Trial
The goal of this clinical trial is to evaluate the feasibility and safety of fetal embolization for severe, otherwise lethal, Vein of Galen Malformation (VOGM) via a laparotomy-assisted approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 participants. The hypothesis is that in utero embolization of severe VOGM will reduce postnatal mortality and morbidity in severe VOGM infants with minimal maternal risks and acceptably low fetal risks.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Participants will be offered the FETTUS technique as an alternative to the traditional standard postnatal VOGM embolization if all study criteria are met. During the surgery, the mother's uterus is exteriorized using the standard laparotomy approach that we currently use for our fetoscopic spina bifida repair and then transuterine fetal cardiac access is obtained under continuous ultrasound guidance. Once the needle is in place, a microcatheter is advanced through the blood vessels in the heart and up to the site of the malformation in the brain. The malformation will be embolized using medical-grade glue (Trufill n-BCA Liquid Embolic System, Johnson & Johnson)
All participants will be closely followed with postoperative ultrasound scans and consultations. Delivery will be scheduled at Texas Children's Hospital, and the infants will be followed by our research team until they reach 24 months of age.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Luc Joyeux, MD, PhD
- 전화번호: 832-822-4398
- 이메일: luc.joyeux@bcm.edu
연구 연락처 백업
- 이름: Karen Chen, MD
- 전화번호: 832-824-5342
- 이메일: karen.chen@bcm.edu
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- Texas Children's Hospital
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부수사관:
- William Whitehead, MD, MPH
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부수사관:
- Luc Joyeux, MD, PhD
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부수사관:
- Magdalena Sanz Cortes, MD, PhD
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부수사관:
- Caitlin Sutton, MD
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연락하다:
- Becky Johnson, MS
- 전화번호: 832-826-7451
- 이메일: rj2@bcm.edu
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연락하다:
- Michael Belfort, MD, PhD
- 전화번호: 832-826-7375
- 이메일: belfort@bcm.edu
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부수사관:
- Becky Johnson, MS, CCRP
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수석 연구원:
- Michael Belfort, MD, PhD
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부수사관:
- Karen Chen, MD
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부수사관:
- Carolyn Altman, MD
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부수사관:
- Jessian Munoz, MD, PhD, MPH
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부수사관:
- Samuel McClugage, MD
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부수사관:
- Howard Weiner, MD
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부수사관:
- Dajana Sabic, DO
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부수사관:
- Lisa Emrick, MD
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부수사관:
- Larry Hollier, MD
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부수사관:
- Thierry Huisman, MD, PhD
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부수사관:
- David Mann, MD, DBe
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Pregnant woman - maternal age 18 years or older
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Singleton pregnancy
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Prenatal sonographic evidence of Vein of Galen Malformation (VOGM) between 23-0/7 and 37-0/7 weeks of gestation
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VOGM volume ratio (VBR) >9.69% and narrowest mediolateral diameter of the straight or falcine sinus (>10.15 mm) on prenatal magnetic resonance imaging (MRI)
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Worsening VOGM severity on follow up prenatal imaging (i.e. ultrasound, MRI and/or echocardiography), and exceeding the specified threshold measurements in any one or more of the following prognostic markers: VOGM varix volume (≥10.9cm3), new or progressive middle cerebral artery pseudofeeders, and/or worsening combined cardiac index (CCI >750 mL/kg/min).
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Absence of bilateral extensive brain damage on fetal MRI
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Absence of significant* fetal anomalies unrelated to VOGM on fetal US and/or MRI imaging
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Gestational age at the time of the procedure will be between 30-0/7 and 37-0/7 weeks
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Negative maternal serological tests for HIV, Hepatitis B and Hepatitis C because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the pregnant woman's HIV status or Hepatitis status is unknown, she must be tested and found to have negative results before enrollment
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The pregnant woman has considered and declined termination of pregnancy
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The pregnant woman meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)
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Signed informed consent by participant and the father of the baby
- Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the fetus.
Exclusion Criteria:
- Extensive fetal brain parenchymal injury or gliosis on fetal MRI, defined as greater than one quarter of supratentorial brain volume consistent with advanced irreversible brain injury
- Severe hydrops fetalis on fetal ultrasound, characterized by large-volume effusions resulting in organ compression, diffuse fetal skin edema, and marked cardiomegaly
- Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Pre-pregnancy body-mass index (BMI) ≥40
- Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
- Technical limitations precluding fetal surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
- Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal medical condition that is a contraindication to surgery or anesthesia, i.e. any inadequately controlled maternal medical condition resulting in an American Society of Anesthesiologists (ASA) Physical Status classification of III or higher
- Low amniotic fluid volume (Amniotic Fluid Index less than 5cm), unresponsive to maternal hydration, if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture
- The pregnant woman does not have a support person (i.e., spouse, partner, family member, or close friend) available to support her for the duration of the pregnancy
- Inability to comply with the travel and follow-up requirements of the trial
- The pregnant woman has severe depression and has not been cleared by a psychiatrist
- The pregnant woman is enrolled or has been enrolled in any another intervention study that affects the mother or fetus
- Maternal contraindications to nonionic contrast agent such as acute thyroid dysfunction and acute kidney injury
- Maternal hypersensitivity to any of the entities associated with the use of nonionic contrast agent. The use of Omnipaque distributed by GE Healthcare company is contraindicated for participants sensitive to any of the components listed on the container package, i.e. Iohexol (Bis(2,3-dihydroxypropyl)-5-[N-(2,3-dihydroxypropyl)-acetamido]-2,4,6-triiodoisophthalamide), edetate calcium disodium and tromethamine
- Maternal hypersensitivity to any of the entities associated with the use of liquid embolic system. The use of Trufill (n-BCA) distributed by Cerenovus - Johnson&Johnson company is contraindicated for participants sensitive to any of the components listed on the container, i.e. n-BCA, Ethiodized Oil and Tantalum Powder
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Fetal Embolization
This is a single arm study in which participants will undergo a one-time intervention of fetal embolization for severe Vein of Galen Malformation. |
Participants will undergo a laparotomy, exteriorization of the uterus, and uterine needle puncture to obtain fetal cardiac access so a catheter can be inserted into an artery and guided up to the site of the malformation. A liquid embolic system (Trufill n-Butyl CyanoAcrylate, Johnson & Johnson) will be used to occlude the dominant arterial pedicle supplying the shunt.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From the date of fetal embolization until the date of discharge from the NICU, or the date of death from any cause, whichever came first, assessed up to 24 months
|
If the fetal survives to delivery and discharge from the neonatal intensive care unit (NICU) |
From the date of fetal embolization until the date of discharge from the NICU, or the date of death from any cause, whichever came first, assessed up to 24 months
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility of FETTUS in Cases of Severe Vein of Galen Malformation
기간: At the end of the fetal embolization procedure
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If all of the following occurs:
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At the end of the fetal embolization procedure
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: At the end of the fetal embolization procedure
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
|
At the end of the fetal embolization procedure
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: At the end of the fetal embolization procedure
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
|
At the end of the fetal embolization procedure
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Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
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From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Maternal length of stay (in days) |
From date of fetal embolization to date of maternal discharge after the in-utero procedure, assessed up to 4 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
|
From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Gestational age at delivery |
From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Birth weight (grams) |
From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
|
From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Umbilical artery pH |
From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: At hospital discharge or date of death, whichever came first, assessed up to 24 months
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
|
At hospital discharge or date of death, whichever came first, assessed up to 24 months
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: At hospital discharge or date of death, whichever came first, assessed up to 24 months
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes: Number of events related to glue migration |
At hospital discharge or date of death, whichever came first, assessed up to 24 months
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: At hospital discharge or date of death, whichever came first, assessed up to 24 months
|
Fetal and infant morbidity and mortality will be assessed using the following outcomes:
|
At hospital discharge or date of death, whichever came first, assessed up to 24 months
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: At 12 and 24 months of age
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Fetal and infant morbidity and mortality will be assessed using the following outcomes:
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At 12 and 24 months of age
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Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: At 12 and 24 months of age
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Fetal and infant morbidity and mortality will be assessed using the following outcomes: Neurodevelopmental outcomes (Developmental Profile Assessment, Capute Scales, Revised Gesell Developmental Schedules) |
At 12 and 24 months of age
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
Maternal morbidity and mortality will be assessed using the following outcomes:
|
From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
|
Safety of FETTUS in Cases of Severe Vein of Galen Malformations
기간: From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
Maternal morbidity and mortality will be assessed using the following outcomes: Number of events related to glue migration |
From date of fetal embolization to date of delivery, assessed up to 10 weeks
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Michael Belfort, MD, PhD, Baylor College of Medicine and Texas Children's Hospital
- 연구 책임자: Luc Joyeux, MD, PhD, Baylor College of Medicine and Texas Children's Hospital
- 연구 책임자: Karen Chen, MD, Baylor College of Medicine and Texas Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- H-57171
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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