Neural Tube DefectsFESSBNCT03315637
Fetal Endoscopic Surgery for Spina Bifida
A study testing Fetoscopic repair of spina bifida in people with Neural Tube Defects and Spina Bifida, Open, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Neural Tube Defects, Spina Bifida, Open, Myelomeningocele
- What is being tested?
- Fetoscopic repair of spina bifida
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to 31 Dec 2024
- Phase
- Interventional
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age > 18 years old
- Singleton pregnancy
- Gestational age between 18 0/7 weeks and 26 6/7 weeks
- Isolated neural tube defect between T1 and S1
- Cerebellar herniation (Chiari type II)
Who cannot join
- Fetal anomalies non related to neural tube defect (NTD) including chromosomal abnormalities
- Body mass index > 35 kg/m2
- Maternal disorders contraindicating surgery
- Genetic anomalies with poor prognosis
- Sever kyphosis (>30º)
Trial locations and contacts
1 site in 1 country.
Elena Carreras, PhD contact
Nerea Maiz, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Elena Carreras, PhD, ecarreras@vhebron.net
Nerea Maiz, PhD, nmaiz@vhebron.net
About this study
This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.
Read the detailed description
Introduction:
Spina bifida is a congenital malformation characterized by a failure in neural tube closure. Unprotected fetal neural tissue at the spine level undergoes not only progressive neurodegeneration in spinal cord, but also the impairment in brain development, hindbrain herniation or Chiari II malformation probably due to pressure disturbances resulting from a continuous leakage of cerebrospinal fluid through the defect. The neurological consequences at birth are irreversible and sometimes devastating, including paraplegia, sphincter urinary and fecal incontinence, hydrocephalus, cranial nerve disturbances, respiratory problems and death due to spinal cord injury and brain maldevelopment.
Intrauterine fetal open repair of the defect has proved to improve hindbrain herniation and decrease the need of cerebrospinal shunting.
Hypothesis:
The investigators hypothesize that minimally invasive surgery of spina bifida is feasible and may minimize surgical aggression and obstetrical complications, with similar neonatal and neurological results.
Intervention:
In this study the investigators propose a fetoscopic skin closure technique. After a maternal laparotomy the uterus is exteriorized, the amniotic cavity is accessed by fetoscopic approach. The placode is dissected from the surrounding tissue and dropped into the opened spinal canal, untethered. Part of the cystic tissue is resected. The edges are then closed to the midline.
Follow up:
After surgery patients are followed up at the Fetal Medicine Unit every one or two weeks.
The mode of delivery is decided according to obstetric criteria. Neonates will be examined at birth, and followed up regularly at least until 30 months. Patients are lifetime followed up by our Multidisciplinary myelomeningocele (MMC) Committee that comprises professionals from the Spina Bifida Unit, Neonatologists, Pediatric Surgeons, Pediatric Urologist, Pediatric Orthopedic Surgeons, Radiologists, Rehabilitation, Pathologists, Pediatric Neurosurgeons, Obstetricians and Fetal Therapists.
- Conditions
- Neural Tube Defects, Spina Bifida, Open, Myelomeningocele, Fetal Disease, Hydrocephalus, Chiari Malformation Type 2
- Being tested
- Fetoscopic repair of spina bifida
- Medical subject headings
- Neural Tube Defects, Spina Bifida Cystica, Meningomyelocele, Fetal Diseases, Hydrocephalus, Arnold-Chiari Malformation, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic repair of spina bifidaProcedure or surgery
Fetoscopic intrauterine repair of open spina bifida
| Study group | Role | What they receive |
|---|---|---|
| Fetoscopic repair of spina bifida | Experimental | This is a single arm study, all patients will receive a fetoscopic repair of the spina bifida Receives: Procedure: Fetoscopic repair of spina bifida |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)
Binary variable (yes/no) describing if the neural tube defect has been successfully closed, (placode dissected and dropped into the open spinal canal, cystic tissue resected and edges closed to the midline), by fetoscopic surgery, and without conversion to open surgery
Measured: Time of procedure (day 0)
Secondary outcomes (3)
Operating time (minutes)
Time between the skin opening and skin closure
Measured: Time of procedure (day 0)
Fetoscopy time (minutes)
Time between the introduction of the first cannula and the removal of the last cannula
Measured: Time of procedure (day 0)
Hospital stay (days)
Time between hospital admission and discharge
Measured: Between procedure and delivery, up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study startJan 2015
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neural Tube DefectsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315637
- Sponsor's protocol ID
- PR(AMI)152/2015
- Acronym
- FESSB
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maroto A, Illescas T, Melendez M, Arevalo S, Rodo C, Peiro JL, Belfort M, Cuxart A, Carreras E. Ultrasound functional evaluation of fetuses with myelomeningocele: study of the interpretation of results. J Matern Fetal Neonatal Med. 2017 Oct;30(19):2301-2305. doi: 10.1080/14767058.2016.1247262. Epub 2017 Jan 16.
PubMed 27997256Belfort MA, Whitehead WE, Shamshirsaz AA, Bateni ZH, Olutoye OO, Olutoye OA, Mann DG, Espinoza J, Williams E, Lee TC, Keswani SG, Ayres N, Cassady CI, Mehollin-Ray AR, Sanz Cortes M, Carreras E, Peiro JL, Ruano R, Cass DL. Fetoscopic Open Neural Tube Defect Repair: Development and Refinement of a Two-Port, Carbon Dioxide Insufflation Technique. Obstet Gynecol. 2017 Apr;129(4):734-743. doi: 10.1097/AOG.0000000000001941.
PubMed 28277363
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Endoscopic Surgery for Spina Bifida
- ClinicalTrials.gov ID
- NCT03315637
- Acronym / sponsor ID
- FESSB / PR(AMI)152/2015
- Conditions
- Neural Tube Defects, Spina Bifida, Open, Myelomeningocele, Fetal Disease, Hydrocephalus, Chiari Malformation Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Oct 2017 (actual)
- 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.
This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.
Detailed description
Introduction:
Spina bifida is a congenital malformation characterized by a failure in neural tube closure. Unprotected fetal neural tissue at the spine level undergoes not only progressive neurodegeneration in spinal cord, but also the impairment in brain development, hindbrain herniation or Chiari II malformation probably due to pressure disturbances resulting from a continuous leakage of cerebrospinal fluid through the defect. The neurological consequences at birth are irreversible and sometimes devastating, including paraplegia, sphincter urinary and fecal incontinence, hydrocephalus, cranial nerve disturbances, respiratory problems and death due to spinal cord injury and brain maldevelopment.
Intrauterine fetal open repair of the defect has proved to improve hindbrain herniation and decrease the need of cerebrospinal shunting.
Hypothesis:
The investigators hypothesize that minimally invasive surgery of spina bifida is feasible and may minimize surgical aggression and obstetrical complications, with similar neonatal and neurological results.
Intervention:
In this study the investigators propose a fetoscopic skin closure technique. After a maternal laparotomy the uterus is exteriorized, the amniotic cavity is accessed by fetoscopic approach. The placode is dissected from the surrounding tissue and dropped into the opened spinal canal, untethered. Part of the cystic tissue is resected. The edges are then closed to the midline.
Follow up:
After surgery patients are followed up at the Fetal Medicine Unit every one or two weeks.
The mode of delivery is decided according to obstetric criteria. Neonates will be examined at birth, and followed up regularly at least until 30 months. Patients are lifetime followed up by our Multidisciplinary myelomeningocele (MMC) Committee that comprises professionals from the Spina Bifida Unit, Neonatologists, Pediatric Surgeons, Pediatric Urologist, Pediatric Orthopedic Surgeons, Radiologists, Rehabilitation, Pathologists, Pediatric Neurosurgeons, Obstetricians and Fetal Therapists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetoscopic repair of spina bifida | Experimental | Procedure: Fetoscopic repair of spina bifidaThis is a single arm study, all patients will receive a fetoscopic repair of the spina bifida |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Maternal age > 18 years old
- Singleton pregnancy
- Gestational age between 18 0/7 weeks and 26 6/7 weeks
- Isolated neural tube defect between T1 and S1
- Cerebellar herniation (Chiari type II)
Key exclusion criteria (5 listed)
- Fetal anomalies non related to neural tube defect (NTD) including chromosomal abnormalities
- Body mass index > 35 kg/m2
- Maternal disorders contraindicating surgery
- Genetic anomalies with poor prognosis
- Sever kyphosis (>30º)
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 |
|---|---|---|
| Fetoscopic repair of spina bifidaFetoscopic intrauterine repair of open spina bifida | Procedure or surgery | Fetoscopic repair of spina bifida |
Primary outcome
Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no)
Time frame: Time of procedure (day 0)
Binary variable (yes/no) describing if the neural tube defect has been successfully closed, (placode dissected and dropped into the open spinal canal, cystic tissue resected and edges closed to the midline), by fetoscopic surgery, and without conversion to open surgery
3 secondary outcomes
Operating time (minutes)
Time frame: Time of procedure (day 0)
Fetoscopy time (minutes)
Time frame: Time of procedure (day 0)
Hospital stay (days)
Time frame: Between procedure and delivery, up to 21 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Background: PubMed 27997256Maroto A, Illescas T, Melendez M, Arevalo S, Rodo C, Peiro JL, Belfort M, Cuxart A, Carreras E. Ultrasound functional evaluation of fetuses with myelomeningocele: study of the interpretation of results. J Matern Fetal Neonatal Med. 2017 Oct;30(19):2301-2305. doi: 10.1080/14767058.2016.1247262. Epub 2017 Jan 16.
- Background: PubMed 28277363Belfort MA, Whitehead WE, Shamshirsaz AA, Bateni ZH, Olutoye OO, Olutoye OA, Mann DG, Espinoza J, Williams E, Lee TC, Keswani SG, Ayres N, Cassady CI, Mehollin-Ray AR, Sanz Cortes M, Carreras E, Peiro JL, Ruano R, Cass DL. Fetoscopic Open Neural Tube Defect Repair: Development and Refinement of a Two-Port, Carbon Dioxide Insufflation Technique. Obstet Gynecol. 2017 Apr;129(4):734-743. doi: 10.1097/AOG.0000000000001941.
Related trials for Neural Tube Defects
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
First-Trimester Screening of Open Neural Tube Defects Using Biometrics and Maternal Serum Markers
Neural Tube Defects (NTDs)
Active, not recruitingPhase 1
Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
Neural Tube Defects
Not yet recruiting
Motor Imagery-Supported Thoracic Expansion in Children With Spina Bifida
Spina Bifida
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.
Elena Carreras, PhD contact
Nerea Maiz, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopic repair of spina bifida in people with Neural Tube Defects and Spina Bifida, Open, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 5 inclusion and 5 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 20 Oct 2017. 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 Spain. 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?
Contact Elena Carreras, PhD (ecarreras@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capability to achieve successful closure of the neural tube defect by fetoscopic surgery (yes/no) (time frame: Time of procedure (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315637, which also lists 2 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 20 Oct 2017.