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FETO Therapy for Diaphragmatic Hernia (FETO Trial)
FETO Trial Summary
This trial is testing a new fetal treatment for left Congenital Diaphragmatic Hernia. If successful, it could be used in future trials with more patients.
FETO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFETO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FETO Trial Design
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Who is running the clinical trial?
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- I am at high risk for early labor due to a short cervix or uterine issues.My unborn baby has a diaphragm issue on the right side, both sides, or isolated left with specific lung measurement.I do not have HIV or Hepatitis, or I have tested negative for them.I am pregnant and 18 years or older.I have a health condition that prevents me from having surgery during pregnancy.I have a uterine condition like fibroids or a developmental abnormality.My baby's genetic test results are normal.I am under 18 years old.A safe method to place a balloon in the womb through a scope is not possible for me.My condition involves a left-sided diaphragmatic hernia with the liver positioned higher.
- Group 1: FETO therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still openings available in this clinical investigation?
"Yes, the data on clinicaltrials.gov specifies that this medical trial is actively in search of participants--with an initial post date of December 1st 2015 and a most recent update occurring June 29th 2022. The research calls for 20 patients at a single site."
How many test subjects are currently being enrolled for this medical trial?
"Affirmative. Data from clinicaltrials.gov implies that this research, which was first announced on December 1st 2015, is recruiting participants. Approximately 20 patients are needed for the single trial site involved in this project."
Who may participate in this experiment?
"This study requires 20 participants of legal age (18-45) with Morgagni hernias to abide by a set of criteria. This includes having a normal fetal karyotype, displaying severe pulmonary hypoplasia on an ultrasound as well being pregnant and singleton. Psychosocial requirements must be met in addition to providing informed consent for the clinical trial."
Does this investigation accept participants over 40 years of age?
"For this trial, there are criteria that must be met to qualify for enrolment. The minimum age is 18 and the maximum age is 45 years old. Additionally, there exists a separate set of clinical trials dedicated to those under 18 as well as an additional 133 studies catering exclusively to seniors over 65."
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