Catheter System for Pulmonary Arterial Hypertension

Waitlist Available
Led By Rodrigo Ruano, M.D., Ph.D.
Research Sponsored by Rodrigo Ruano M.D., Ph.D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient meets psychosocial criteria
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Screening 3 weeks
Treatment Varies
Follow Upup to 24 months post partum
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new medical procedure to see if it is safe and effective.

Eligible Conditions
  • Pulmonary Hypoplasia
  • Pulmonary Arterial Hypertension
  • Congenital Diaphragmatic Hernia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You meet certain mental and emotional requirements.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post partum
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post partum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of unplanned balloon removal
Gestational Age at Delivery
Number of incidences of maternal complications
+3 more
Secondary outcome measures
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Growth as measured via LHR
Fetal survival
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FETO GroupExperimental Treatment2 Interventions
Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.

Find a site

Who is running the clinical trial?

Rodrigo Ruano M.D., Ph.DLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Rodrigo RuanoLead Sponsor
3 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
10 Patients Enrolled for Pulmonary Arterial Hypertension
Rodrigo Ruano, M.D., Ph.D.Principal Investigator
University of Miami
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

BALT GoldbBAL2 Detachable Balloon (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03138863 — N/A
Pulmonary Arterial Hypertension Research Study Groups: FETO Group
Pulmonary Arterial Hypertension Clinical Trial 2023: BALT GoldbBAL2 Detachable Balloon Highlights & Side Effects. Trial Name: NCT03138863 — N/A
BALT GoldbBAL2 Detachable Balloon (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03138863 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available to join this investigation?

"According to, this research project is no longer accepting participants. Initially made available on February 8th 2023, the trial was last updated November 21st 2022. Although not recruiting subjects anymore, there are still 244 other trials that require volunteers for their studies."

Answered by AI

Who qualifies for the opportunity to take part in this research project?

"This clinical trial is currently searching for 10 individuals with Morgagni hernias, aged between 18 and 50. Those who wish to participate must meet the following criteria: single pregnancy, isolated left congenital diaphragmatic hernia with liver up, gestational age prior to 29 weeks 6 days (as measured via ultrasound), a lung-to head circumference ratio of less than 25% from 180 - 296 weeks gestation, greater than or equal to 25%, but less than 30% from 300 - 316 weeks gestation; psychosocial fitness as determined by an evaluation team; normal fetal karyotype confirmed through culture results or fluorescence in"

Answered by AI

Are there any particular goals this clinical trial seeks to accomplish?

"This clinical trial will assess the Gestational Age at Delivery over a maximum of 34 weeks. Secondary objectives are to quantify the Number of days of ventilator support, neonatal intensive care unit residency and Diaphragmatic Repair experienced by recruited infants."

Answered by AI

Are participants over 25 years of age eligible for this research trial?

"This clinical trial is restricted to patients aged 18-50. If a participant does not meet this criteria, there are 30 studies available for those under the age of majority and 204 for senior citizens above 65 years old."

Answered by AI
~NaN spots leftby Nov 2023