New York, NYNCT05354505Now EnrollingIRB Ready

Diaphragmatic Hernia Clinical Trial in New York, NY

Access cutting-edge diaphragmatic hernia treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Vincent Duron

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Expert Care in New York

Access diaphragmatic hernia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related diaphragmatic hernia treatment provided free

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Check if you qualify for this diaphragmatic hernia clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Diaphragmatic Hernia Study in New York

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

Sponsor: Vincent Duron

Who Can Participate

Inclusion Criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
Pregnant women, age 18 years and older
Singleton pregnancy
No pathogenic variants on microarray or pathologic findings on karyotype; results by fluorescence in situ hybridization (FISH) will be acceptable if patient is \>26 weeks
Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \<25% with liver up
Gestational age at FETO procedure: if o/e LHR \<25%, will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
Meets psychosocial criteria
Willing to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) and ability to maintain follow up appointments. NYP/CUIMC will work with the study participant to assist in securing housing 30 minutes from the hospital if this is a challenge to her.
Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC)
Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

Exclusion Criteria

Multi-fetal pregnancy
History of latex allergy
History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
Psychosocial ineligibility
Inability to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) or inability to maintain follow up appointments
Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
Maternal contraindications to elective fetoscopic surgery
Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
No safe or feasible fetoscopic approach to balloon placement
Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
Participation in another intervention study that influences maternal and fetal morbidity and mortality.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT05354505) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diaphragmatic Hernia Treatment Options in New York, NY

If you're searching for diaphragmatic hernia treatment options in New York, NY, this clinical trial (NCT05354505) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diaphragmatic hernia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diaphragmatic hernia clinical trials near you to find additional studies recruiting in your area.

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