Pulmonary Hypertension Trial, Recruiting NCT03138863 Sponsor: Rodrigo Ruano Condition: Pulmonary Hypertension
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Pulmonary Hypertension Trial, Recruiting

NCT03138863
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The pregnancy involves only one baby (not twins or more)
  • The baby's chromosomes have been confirmed as normal through lab testing (a specific rapid test result may be acceptable if the pregnancy is past 26 weeks)
  • The baby has been diagnosed with a left-sided congenital diaphragmatic hernia (a gap in the diaphragm) where the liver has moved up into the chest cavity, and no other abnormalities have been found
  • The pregnancy is before 29 weeks and 6 days at the time of joining, and scans show the baby's lungs are severely underdeveloped based on specific measurements (confirm exact measurement thresholds with trial site)
  • The procedure must be performed within specific pregnancy week windows depending on the lung measurement results (confirm exact timing windows with trial site)
  • Psychosocial criteria set by the trial site have been met

Who may not be able to join:

  • The pregnancy involves more than one baby
  • There is a known allergy to natural rubber latex
  • There are signs of early labour, the cervix is shorter than 15mm, there is a uterine condition that strongly increases the risk of early labour, or the placenta is positioned over the cervix (placenta previa)
  • Psychosocial factors mean that meaningful consent cannot be given
  • The person would not be able to live within a 30-minute drive of the hospital, or would not be able to attend required follow-up visits
  • There is no support person (such as a partner, spouse, or parent) who is able to stay with the patient at the hospital for the remainder of the pregnancy
  • The hernia is on the right side, affects both sides, or the lung measurements do not fall within the severity range required by the trial
  • The baby has been found to have any additional physical abnormalities or chromosomal problems on scan, MRI, or heart assessment at the treatment centre
  • There is a medical reason the mother cannot undergo the type of surgery used in this trial, or there is a serious medical condition during the pregnancy
  • There is a history of cervical incompetence (a cervix that opens too early), with or without a stitch in place
  • There are known problems with the placenta's position or attachment at the time of joining the trial
  • There is a blood compatibility issue between the mother and baby affecting this pregnancy (confirm specific types with trial site)
  • The mother has HIV, Hepatitis B, or Hepatitis C; if status is unknown, negative test results must be confirmed before the trial site can consider enrolment
  • There is a significant uterine abnormality, such as large or multiple fibroids, or a structural uterine difference present from birth
  • The person is already taking part in another study that may affect outcomes for the mother or baby, or has previously participated in this same trial in an earlier pregnancy

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rodrigo Ruano, M.D., Ph.D., University of Miami

Phone: 305.689.8001

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Rodrigo Ruano
Registry
ClinicalTrials.gov
Start date
1 May 2024
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of successfully completed FETO procedures; Operative time; Frequency of unplanned balloon removal; Number of incidences of maternal complications; Number of participants with maternal complications; Gestational Age at Delivery

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov