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MyelomeningoceleENDOSPINNCT02390895

Prenatal Endoscopic Repair of Fetal Spina Bifida

A study testing endoscopic repair of myelomeningocele before 26 SA in people with Myelomeningocele, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Myelomeningocele
What is being tested?
endoscopic repair of myelomeningocele before 26 SA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteFrance
Study dates
17 May 2017to 6 Jul 2022
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient > 18 years old, with an assumption by health insurance, understanding and speaking French
  • A term < or = 26 +0 weeks gestational age
  • Single-Pregnancy
  • Myelomeningocele with higher-level defect between S1 and T1
  • Arnold Chiari anomaly
  • No associated anomaly or chromosic anomaly

Who cannot join

  • severe foetal kyphoscoliosis associated
  • Increased risk of preterm birth: cervical length <15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane
  • placenta previa, accreta or placental abruption
  • Maternal obesity with BMI> 35
  • Uterine anomalies : large interstitial uterine fibroid, uterine malformation
  • maternal infection with a foetal transmission risk: HIV, HBV, HCV
Show all 10Show fewer
  • Maternal contradiction in surgery or anesthesia
  • poor social status and/or social isolation
  • impossible post-surgery follow-up
  • want to have a medical pregnancy termination

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Necker Enfants Malades

    Paris, 75015

Other trials in France

About this study

The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

Read the detailed description

Compared with an open approach involving laparotomy and hysterotomy, an endoscopic approach for the prenatal surgery of myelomeningocele offers at least two potential advantages: i) it may reduce the maternal and obstetric morbidity related to the hysterotomy; ii) it may be performed earlier in gestation than open surgery, therefore potentially further reducing exposition of the spinal chord to the intraamniotic environment and thus improving the overall prognosis of the malformation. This study aims to evaluate the feasibility and potential benefits of a minimally invasive endoscopic procedure for the prenatal treatment of myelomeningocele in a single-center trial.

Technically the procedure will be performed through 2 intra-amniotic ports, under fetoscopic visualization and intra-amniotic carbon dioxide insufflation. The defect will be dissected and the cord replaced in the canal. Closure will be performed by suturing paravertebral muscles using a barbed running suture. A Duragen patch will be sutured when primary closure is deemed impossible.

Being tested
endoscopic repair of myelomeningocele before 26 SA
Keywords
Minimally-invasive endoscopic repair, fetal surgery, outcome, Foetus
Medical subject headings
Meningomyelocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic repair of myelomeningocele before 26 SAProcedure or surgery

    prenatal minimally-invasive fetoscopic closure with iii) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation iv) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

Study groups in NCT02390895
Study groupRoleWhat they receive
Minimally-invasive endoscopic repairExperimentalendoscopic repair of myelomeningocele before 26 SA
Receives: Procedure: endoscopic repair of myelomeningocele before 26 SA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful surgery

    Composite criteria:

    1. dissection of the placode
    2. primary coverage or use of a patch
    3. using only endoscopy with two trocars

    Measured: Before 26 gestational weeks

  2. Neonatal surgery

    Need for neonatal surgery

    Measured: Day 0 (birth of neonates)

  3. Arnold Chiari anomaly at birth

    the existence of an Arnold Chiari anomaly at birth

    Measured: Day 0 (birth of neonates)

  4. Ventriculo-peritoneal shunt

    Ventriculo-peritoneal shunt within the 6 months after birth

    Measured: Within the 6 months after birth

  5. Level of injury

    Measured: Within the 6 months after birth

  6. Foetal morbidity

    Composite criteria:

    Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events

    Measured: From surgery to delivery

  7. Motor lower limb improvement outcomes

    Measured: Within the 6 months after birth

  8. Maternal morbidity

    Composite criteria:

    Stillbirth; Premature Rupture of Membranes; Preterm birth; Chorioamnionitis; Hemorrhagic complications during the peri-operative period; Other serious adverse events

    Measured: From surgery to delivery

Secondary outcomes (1)

  1. Neurological development

    Composite criteria:

    Motor deficit medullary reflex orthopedic anomalies consequences on perinea and sphincter

    Measured: Within the 12 months after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2015 (estimated)
  2. Study start17 May 2017
  3. Primary completion6 Jul 2022
  4. Study completion6 Jul 2022

Resources

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390895
Sponsor's protocol ID
P141202
Other IDs
2014-A01948-39
Acronym
ENDOSPIN
Status last verified
Sep 2025
First submitted
15 Feb 2015
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kohl T. Percutaneous minimally invasive fetoscopic surgery for spina bifida aperta. Part I: surgical technique and perioperative outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):515-24. doi: 10.1002/uog.13430.

    PubMed 24891102

  • Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9.

    PubMed 21306277

  • Degenhardt J, Schurg R, Winarno A, Oehmke F, Khaleeva A, Kawecki A, Enzensberger C, Tinneberg HR, Faas D, Ehrhardt H, Axt-Fliedner R, Kohl T. Percutaneous minimal-access fetoscopic surgery for spina bifida aperta. Part II: maternal management and outcome. Ultrasound Obstet Gynecol. 2014 Nov;44(5):525-31. doi: 10.1002/uog.13389.

    PubMed 24753062

  • Verbeek RJ, Heep A, Maurits NM, Cremer R, Hoving EW, Brouwer OF, van der Hoeven JH, Sival DA. Fetal endoscopic myelomeningocele closure preserves segmental neurological function. Dev Med Child Neurol. 2012 Jan;54(1):15-22. doi: 10.1111/j.1469-8749.2011.04148.x. Epub 2011 Nov 29.

    PubMed 22126123

  • Arthuis C, James S, Bussieres L, Hovhannisyan S, Corroenne R, Ville Y, Stirnemann JJ. Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France. Fetal Diagn Ther. 2022;49(9-10):377-384. doi: 10.1159/000525552. Epub 2022 Aug 31.

    PubMed 36044834

Questions about this trial

What is this clinical trial studying?

A study testing endoscopic repair of myelomeningocele before 26 SA in people with Myelomeningocele, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 6 inclusion and 10 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: finished, as of the sponsor's last update on 8 Sep 2025. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Successful surgery (time frame: Before 26 gestational weeks). The study lists 8 primary outcomes in all. 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 NCT02390895, which also lists 5 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 8 Sep 2025.

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