Severe Congenital Diaphragmatic HerniaNCT00768703
Percutaneous Endoscopic Tracheal Plug/Unplug for CDH (Congenital Diaphragmatic Hernia)
A study testing Percutaneous endoscopic fetal tracheal occlusion/unocclusion in people with Severe Congenital Diaphragmatic Hernia, run by University of California, San Francisco at 1 site in United States.
Trial summary
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Severe Congenital Diaphragmatic Hernia
- What is being tested?
- Percutaneous endoscopic fetal tracheal occlusion/unocclusion
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CDH
- Normal fetal echocardiogram
- Normal karyotype
- Fetal liver herniated into the left hemithorax
- Lung-head ratio (LHR) is 1.0 or less, calculated between 24-26 weeks' gestation
- Fetus is between 26 and 28 weeks' gestation
Show all 9Show fewer
- Singleton pregnancy
- Mother meets psychosocial criteria
- Pre-authorization from third-party payor for fetal intervention, or ability to self-pay.
Who cannot join
- Failure to meet all inclusion criteria
- Other congenital anomalies detected on ultrasound
- Contraindication to abdominal surgery or general anesthesia
- Allergy to latex
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
- Family unable or refuses to stay in San Francisco for duration of the tracheal occlusion period and for the duration of the pregnancy as medically necessary.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco Fetal Treatment Center
San Francisco, California, 94143
About this study
Official title: Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. In the most severe cases, there is significant morbidity and mortality at birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. This unblinded, non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.
- Conditions
- Severe Congenital Diaphragmatic Hernia
- Being tested
- Percutaneous endoscopic fetal tracheal occlusion/unocclusion
- Keywords
- Congenital diaphragmatic hernia, lung-head ratio, percutaneous tracheal occlusion, fetal intervention
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous endoscopic fetal tracheal occlusion/unocclusionDevice
Also called Goldvalve Balloon and MiniTorquer Delivery Microcatheter
Between 26-28 wks' gestation, percutaneous endoscopic placement of the tracheal balloon. Between 32-34 wks' gestation, percutaneous endoscopic removal of the balloon.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Severe Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanmin Lee, University of California, San Francisco
- Investigators
- Hanmin Lee, MD, Principal investigator, University of California, San Francisco Fetal Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768703
- Sponsor's protocol ID
- 10-01765
- Other IDs
- TO CDH
- Status last verified
- Mar 2019
- First submitted
- 6 Oct 2008
- Last updated
- 27 Mar 2019
- Results posted
- No
Publications
Jani JC, Nicolaides KH, Gratacos E, Vandecruys H, Deprest JA; FETO Task Group. Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. doi: 10.1016/j.ajog.2006.04.004. Epub 2006 Jun 12.
PubMed 16769018Done E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033.
PubMed 18634116Cortes RA, Keller RL, Townsend T, Harrison MR, Farmer DL, Lee H, Piecuch RE, Leonard CH, Hetherton M, Bisgaard R, Nobuhara KK. Survival of severe congenital diaphragmatic hernia has morbid consequences. J Pediatr Surg. 2005 Jan;40(1):36-45; discussion 45-6. doi: 10.1016/j.jpedsurg.2004.09.037.
PubMed 15868556Keller RL, Hawgood S, Neuhaus JM, Farmer DL, Lee H, Albanese CT, Harrison MR, Kitterman JA. Infant pulmonary function in a randomized trial of fetal tracheal occlusion for severe congenital diaphragmatic hernia. Pediatr Res. 2004 Nov;56(5):818-25. doi: 10.1203/01.PDR.0000141518.19721.D7. Epub 2004 Aug 19.
PubMed 15319458Harrison MR, Keller RL, Hawgood SB, Kitterman JA, Sandberg PL, Farmer DL, Lee H, Filly RA, Farrell JA, Albanese CT. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003 Nov 13;349(20):1916-24. doi: 10.1056/NEJMoa035005.
PubMed 14614166Harrison MR, Albanese CT, Hawgood SB, Farmer DL, Farrell JA, Sandberg PL, Filly RA. Fetoscopic temporary tracheal occlusion by means of detachable balloon for congenital diaphragmatic hernia. Am J Obstet Gynecol. 2001 Sep;185(3):730-3. doi: 10.1067/mob.2001.117344.
PubMed 11568805Ruano R, Ali RA, Patel P, Cass D, Olutoye O, Belfort MA. Fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia: indications, outcomes, and future directions. Obstet Gynecol Surv. 2014 Mar;69(3):147-58. doi: 10.1097/OGX.0000000000000045.
PubMed 25102346Done E, Gratacos E, Nicolaides KH, Allegaert K, Valencia C, Castanon M, Martinez JM, Jani J, Van Mieghem T, Greenough A, Gomez O, Lewi P, Deprest J. Predictors of neonatal morbidity in fetuses with severe isolated congenital diaphragmatic hernia undergoing fetoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2013 Jul;42(1):77-83. doi: 10.1002/uog.12445.
PubMed 23444265
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Endoscopic Tracheal Plug/Unplug for Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT00768703
- Acronym / sponsor ID
- 10-01765
- Conditions
- Severe Congenital Diaphragmatic Hernia
- Keywords
- Congenital diaphragmatic hernia, lung-head ratio, percutaneous tracheal occlusion, fetal intervention
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- First posted
- 8 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. Herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. In the most severe cases, there is significant morbidity and mortality at birth. For these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. This unblinded, non-randomized trial will assess the safety and efficacy of the use of the Goldvalve balloon and MiniTorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe CDH in utero. The primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (LHR) measurements. Secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. For infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the Long-term Infant-to-Adult Follow-up Evaluation (LIFE) Clinic at UCSF.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed diagnosis of CDH
- Normal fetal echocardiogram
- Normal karyotype
- Fetal liver herniated into the left hemithorax
- Lung-head ratio (LHR) is 1.0 or less, calculated between 24-26 weeks' gestation
Key exclusion criteria (6 listed)
- Failure to meet all inclusion criteria
- Other congenital anomalies detected on ultrasound
- Contraindication to abdominal surgery or general anesthesia
- Allergy to latex
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous endoscopic fetal tracheal occlusion/unocclusionAlso: Goldvalve Balloon and MiniTorquer Delivery MicrocatheterBetween 26-28 wks' gestation, percutaneous endoscopic placement of the tracheal balloon. Between 32-34 wks' gestation, percutaneous endoscopic removal of the balloon. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Background: PubMed 16769018Jani JC, Nicolaides KH, Gratacos E, Vandecruys H, Deprest JA; FETO Task Group. Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. doi: 10.1016/j.ajog.2006.04.004. Epub 2006 Jun 12.
- Background: PubMed 18634116Done E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033.
- Background: PubMed 15868556Cortes RA, Keller RL, Townsend T, Harrison MR, Farmer DL, Lee H, Piecuch RE, Leonard CH, Hetherton M, Bisgaard R, Nobuhara KK. Survival of severe congenital diaphragmatic hernia has morbid consequences. J Pediatr Surg. 2005 Jan;40(1):36-45; discussion 45-6. doi: 10.1016/j.jpedsurg.2004.09.037.
- Background: PubMed 15319458Keller RL, Hawgood S, Neuhaus JM, Farmer DL, Lee H, Albanese CT, Harrison MR, Kitterman JA. Infant pulmonary function in a randomized trial of fetal tracheal occlusion for severe congenital diaphragmatic hernia. Pediatr Res. 2004 Nov;56(5):818-25. doi: 10.1203/01.PDR.0000141518.19721.D7. Epub 2004 Aug 19.
- Background: PubMed 14614166Harrison MR, Keller RL, Hawgood SB, Kitterman JA, Sandberg PL, Farmer DL, Lee H, Filly RA, Farrell JA, Albanese CT. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003 Nov 13;349(20):1916-24. doi: 10.1056/NEJMoa035005.
- Background: PubMed 11568805Harrison MR, Albanese CT, Hawgood SB, Farmer DL, Farrell JA, Sandberg PL, Filly RA. Fetoscopic temporary tracheal occlusion by means of detachable balloon for congenital diaphragmatic hernia. Am J Obstet Gynecol. 2001 Sep;185(3):730-3. doi: 10.1067/mob.2001.117344.
- Background: PubMed 25102346Ruano R, Ali RA, Patel P, Cass D, Olutoye O, Belfort MA. Fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia: indications, outcomes, and future directions. Obstet Gynecol Surv. 2014 Mar;69(3):147-58. doi: 10.1097/OGX.0000000000000045.
- Background: PubMed 23444265Done E, Gratacos E, Nicolaides KH, Allegaert K, Valencia C, Castanon M, Martinez JM, Jani J, Van Mieghem T, Greenough A, Gomez O, Lewi P, Deprest J. Predictors of neonatal morbidity in fetuses with severe isolated congenital diaphragmatic hernia undergoing fetoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2013 Jul;42(1):77-83. doi: 10.1002/uog.12445.
- UCSF Fetal Treatment CenterLink provided by the sponsor.
Related trials for Severe Congenital Diaphragmatic Hernia
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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
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Recruiting
North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanmin Lee, MD principal investigator
University of California, San Francisco Fetal Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous endoscopic fetal tracheal occlusion/unocclusion in people with Severe Congenital Diaphragmatic Hernia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768703, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.