Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
ConditionCongenital Diaphragmatic Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMauro H. Schenone
About this trial
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton pregnancy
Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
Isolated severe left CDH with O/E LHR < 25% )
Gestation age at enrollment prior to 29 wks plus 6 days.
Disqualifiers
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (<20 mm) at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor
Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester and inability to comply with the travel for the follow-up requirements of the trial; patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic
Trial design
Design model
Single group
Treatments tested in this trial
BALT GOLDBALL 2 detachable latex ballon
DeviceInflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
BALTACCIBDPE100 Microcatheter
DeviceUsed to deliver the detachable balloon
Storz fetoscopic operating sheath and miniature telescope/fetoscope
DeviceUsed to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: FETO GroupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Technical success of the balloon placement procedure
The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.
Time frame
Up to 29 weeks gestation2
Technical success of balloon retrieval procedure
The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
Time frame
Up to 34 weeks gestation3
Operative times
FETO placement and release operative times reported in minutes
Time frame
Up to 34 weeks gestation4
Frequency of unplanned balloon removal
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Time frame
Up to 34 weeks gestationSecondary outcomes
1
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Volume as measured via ultrasound
Time frame
Up to 24 months post partum2
Fetal Lung Growth as measured via LHR
Lung area to head circumference Ratio (LHR) as measured via ultrasound
Time frame
Up to 24 months post partum3
Fetal Survival
Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized
Time frame
Up to 6 months post partum4
Fetal Oxygen Dependency
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Time frame
Up to 24 months post partumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mauro H. Schenone
Lead sponsor
Mayo Clinic
Sponsor institution
Source ClinicalTrials.gov