Fetal Tracheal Balloon Study in Diaphragmatic Hernia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00966823
Recruitment Status : Terminated (Device no longer available)
First Posted : August 27, 2009
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Francois Luks, Rhode Island Hospital

August 26, 2009
August 27, 2009
July 3, 2015
May 30, 2017
May 30, 2017
September 2008
January 2015   (Final data collection date for primary outcome measure)
Newborn Survival at Birth [ Time Frame: Newborn period (1 day) ]
Survival at birth [ Time Frame: Newborn period (1 day) ]
Complete list of historical versions of study NCT00966823 on Archive Site
  • Newborn Survival at 30 Days [ Time Frame: 30 days ]
  • Maternal Complications [ Time Frame: Intervention to 30 days postpartum ]
  • Fetal Morbidity [ Time Frame: Intervention to delivery ]
    Fetal morbidity, fetal mortality
  • Number of Participants With In Utero Lung Growth (LHR) >1.4 [ Time Frame: Intervention to 2 weeks post-intervention ]
    Inclusion criterion for the study is LHR<0.9 (extreme pulmonary hypoplasia). Given that LHR is relatively constant during 2nd and 3rd trimester of gestation, "In utero lung growth" is defined as LHR>1.4 (definition of mild/moderate pulmonary hypoplasia) within 2 weeks of intervention. Outcome measure = number of participants with LHR>1.4 at 2 weeks post-intervention
  • Survival at 30 days [ Time Frame: 30 days ]
  • Maternal Complications [ Time Frame: 30 days ]
  • Fetal Morbidity [ Time Frame: 30 days ]
  • In utero lung growth (LHR) [ Time Frame: 30 days ]
Not Provided
Not Provided
Fetal Tracheal Balloon Study in Diaphragmatic Hernia
Phase 2 Fetal Tracheal Balloon (IDE G080077) Study in Diaphragmatic Hernia
The purpose of this phase 2 limited study is to examine whether prenatal intervention correct the lung underdevelopment associated with severe diaphragmatic hernia.

Congenital diaphragmatic hernia (CDH) has traditionally been associated with very high mortality rates. Most infants died of pulmonary hypoplasia and severe pulmonary hypertension. This led to correction of CDH and pulmonary hypoplasia before birth. Unfortunately, maternal morbidity of open fetal surgery was significant and fetal mortality was very high (>60%). Moreover, the results of postnatal therapy for CDH improved dramatically, from less than 20% survival several decades ago to more than 70% today.

Fetal intervention has evolved as well, to a minimally invasive approach that involves a single endoscopic port and occlusion of the fetal trachea. While this has considerably decreased the morbidity and fetal mortality of the in utero procedure, its results do not exceed the overall (i.e., non-stratified) results of contemporary postnatal treatment. Most recently, a multicentric cooperative study under (Eurofoetus) has conducted a clinical trial comparing postnatal treatment with endoscopic fetal tracheal occlusion for the most severe forms of CDH. Results of the Eurofoetus trial and of a recent retrospective review involving European and North-American centers have shown the following: 1) It is possible to identify a specific subgroup of fetuses with CDH in whom survival can be predicted to be less than 10%, despite all current methods of postnatal treatment, 2) Survival of fetuses with predicted postnatal survival of 8% was >50% following endoscopic fetal tracheal occlusion, and 3) Fetal tracheal occlusion in that group resulted in an increase in lung size (LHR), from an average of 0.7 pre-intervention, to 1.7 post-intervention.

Based on the available research literature, the results of the Eurofoetus trial, and this institution's experience with endoscopic fetal surgery, we hypothesize that in the highest risk group of fetuses with congenital diaphragmatic hernia, where chances of survival is estimated at less than 10%, endoscopic fetal tracheal occlusion in late second trimester, with reversal of occlusion in mid-third trimester, allows catch-up lung growth and maturation and converts the condition into one with intermediate to good prognosis (predicted survival 50-60%). We propose to offer this form of treatment, under an FDA-approved Investigational Device Exemption (G080077), to eligible patients, on a case-by-case basis, after discussion before a multidisciplinary board.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diaphragmatic Hernia
  • Lung Disease
Device: Fetal tracheal obstruction with detachable balloon (device)

Fetal tracheal obstruction with detachable balloon (device): Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.

- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.

Other Name: Goldvalve Balloon, nFocus Neuromedical, Inc.
Experimental: Detachable balloon
Intervention: Fetuses treated with endoscopic tracheal occlusion
Intervention: Device: Fetal tracheal obstruction with detachable balloon (device)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Singleton pregnancies
  • Isolated congenital diaphragmatic hernia
  • Normal karyotype (amniocentesis)
  • Initial diagnosis before 26 weeks gestation
  • Competent cervix
  • Severity of CDH: lung-to-head ratio (LHR) ≤0.8 at 22-26 weeks gestation
  • Liver herniation in the chest
  • Informed consent

Exclusion Criteria:

  • Preterm labor, premature rupture of membranes or amniotic leak
  • Significant maternal morbidity
  • Minor (<18 years)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Francois Luks, Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Francois I Luks, MD, PhD Rhode Island Hospital
Rhode Island Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP