Surgical Devices for Neural Tube Defects

Overseen By Michael A Belfort, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michael A Belfort

Disqualifiers: Not electing for repair

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new surgical tools to determine their safety and effectiveness in fixing neural tube defects (problems with the spine and brain) before birth. The study focuses on using modified instruments during fetoscopic (minimally invasive) surgery to repair these defects. It targets patients who have chosen this specific type of surgery for their unborn child. Participants help researchers assess whether these new devices improve the surgery's safety or effectiveness. As an unphased trial, this study provides a unique opportunity for patients to contribute to pioneering research that could enhance surgical outcomes for future families.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these surgical devices are safe for fetoscopic neural tube defect repair?

Research has shown that using specially designed surgical tools, such as protective covers and cleaning devices, during fetoscopic surgery (a type of minimally invasive surgery) to repair neural tube defects is safe. These tools have proven effective in similar surgeries. For instance, one study confirmed the safety of a specific fetoscopic method used to fix neural tube defects, indicating that the tools used in these surgeries are generally safe for patients. So far, no reports have indicated serious problems directly caused by these devices. While additional research could provide further reassurance, current evidence supports the safety of these surgical tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the modified surgical devices for neural tube defects (NTDs) because they offer a new approach to fetal surgery. Unlike traditional open fetal surgery, which involves larger incisions and more invasive techniques, these modified instruments are used in a less invasive procedure known as fetoscopic repair. This approach aims to reduce risks associated with open surgery, such as preterm labor and maternal complications, by utilizing specialized sheaths and irrigators for a more precise and minimally invasive repair. This innovative technique could significantly improve outcomes for both mothers and babies, making it a promising advancement in the treatment of NTDs.

What evidence suggests that these modified surgical devices are effective for neural tube defect repair?

Research has shown that specially designed surgical tools, such as protective covers and cleaning devices, are being tested for their effectiveness in treating neural tube defects during fetoscopic surgery. Early results suggest these tools can enhance the procedure's safety and success. In this trial, all participants will undergo fetoscopic neural tube defect repair using these modified devices. One study found that using these tools in a specific repair technique was both feasible and effective for fixing defects. This method has proven successful, offering a promising way to treat this condition. These tools aim to improve the surgery's safety for both mothers and babies. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael A Belfort, MD

Principal Investigator

Baylor College of Medicine and Texas Children's Hospital

Are You a Good Fit for This Trial?

This trial is for patients choosing to have fetoscopic repair for neural tube defects like Spina Bifida. It's not open to those who decide against this specific type of fetal surgery.

Inclusion Criteria

I am choosing to have surgery for a spinal defect in my unborn baby.

Exclusion Criteria

I have chosen not to have surgery for a fetal condition before birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fetoscopic Procedure

Participants undergo fetoscopic neural tube defect repair using modified devices

Immediate procedure

1 visit (in-person)

Immediate Post-Procedure Follow-up

Participants are monitored for device performance and adverse events until they leave the OR

Immediate post-procedure period

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Trial Overview The study is testing the safety and effectiveness of modified surgical tools, including special sheaths and irrigators, used during fetoscopic repair procedures for neural tube defects.

How Is the Trial Designed?

Group I: Modified Devices in fetoscopic NTD repair Experimental Treatment 1 Intervention

Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices.

Modified Surgical Instruments/Devices (Sheaths and Irrigator) is already approved in United States for the following indications:

Approved in United States as Modified Surgical Instruments/Devices for:

• Fetoscopic neural tube defect repair

Who Is Running the Clinical Trial?

Michael A Belfort

Lead Sponsor

Trials

5

Recruited

510+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

The study focuses on developing new technology and equipment for producing precision glass tubes for medical instruments, which could enhance the quality and reliability of medical devices.

The research includes both theoretical and experimental results, indicating a comprehensive approach to ensure the technology's effectiveness and potential applications in the medical field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prospects of the use of new technology for producing precision instruments from glass]. Varta'niants, ATs., Zhelnina, LI., Seliavina, NN., et al.[2011]

The irrigation device is designed to effectively flush out bubbles and blood clots from catheter hubs during neuroangiographic procedures, which can enhance the safety and efficacy of these interventions.

Additionally, the device can prevent air from entering the catheter when a guide wire is removed, potentially reducing complications associated with air embolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irrigation device for neuroangiographic procedures. Choi, IP., Berenstein, A., Kagetsu, NJ.[2010]

The article reviews key neurointerventional tools approved in the U.S., such as catheters, coils, and stents, highlighting their importance in treating neurological conditions.

It emphasizes the significant advancements in these devices over decades, showcasing how technical developments have improved their efficacy and safety in medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular tools available for the treatment of cerebrovascular disease. Griessenauer, CJ., Foreman, P., Deveikis, JP., et al.[2014]

A new irrigation and aspiration device for the cortex has been developed, featuring a specialized design that includes a module and a disposable pack.

The method of use for this device is outlined, suggesting it may improve efficiency and safety in surgical procedures involving the cortex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An inexpensive semiautomated irrigation/aspiration system. Sheets, JH.[2019]

Recent advancements in endovascular aortic repair (EVAR) technology have made it possible to treat patients with small and tortuous iliac access vessels, enhancing the safety and effectiveness of minimally invasive aneurysm treatments.

Improvements in stent-graft design, including features for repositioning and sealing, allow for better treatment of challenging vascular anatomies, emphasizing the need for interventionalists to be well-versed in various materials and techniques for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New developements in endovascular infrarenal aortic aneurysm treatment]. Maßmann, A., Shayesteh-Kheslat, R., Frenzel, F., et al.[2022]

Modifications to endovascular grafts for abdominal aortic aneurysms have been driven by clinical experiences, allowing for better treatment of patients with challenging anatomical features, such as shorter necks and smaller access vessels.

The development process for modified vascular devices includes rigorous evaluations to ensure their safety and effectiveness, adhering to international standards like ISO 25539, which helps ensure that new designs meet clinical needs before they are released to the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manufacturer evaluations of endograft modifications. Waninger, MS., Whirley, RG., Smith, LJ., et al.[2013]

The double-spring pre-curved cannula (DSPC) was developed to enhance surgical access with a small diameter of 3.9 mm and high stiffness, allowing for effective electrocauterization in hard-to-reach areas.

In cadaveric studies, the DSPC successfully accessed the inferior glenohumeral ligament, demonstrating its potential to outperform conventional surgical instruments in specific surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel arthroscopic pre-curved cannula with both flexibility and high stiffness. Park, C., Kim, J., Moon, Y., et al.[2022]

The study introduces a simulation-based method for designing specialized neuroendoscopic instruments tailored for procedures like endoscopic third ventriculostomy and tumor biopsy, using pre-operative CT and MRI images.

This innovative approach provides detailed instrument specifications, such as lengths and curvatures, while ensuring they fit within anatomical boundaries and account for surgical tools, potentially improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design optimization of neuroendoscopic continuum instruments for third ventriculostomy and tumor biopsy. Eastwood, KW., Looi, T., Naguib, HE., et al.[2020]

Laparoscopic surgery is emerging as a viable treatment option for aortoiliac occlusive or aneurysmal diseases, with over 150 patients successfully undergoing laparoscopic aortic reconstructions, highlighting its potential efficacy.

The development of specialized laparoscopic instruments is crucial for improving surgical efficiency and reducing the learning curve, which could enhance the adoption of these minimally invasive techniques among vascular surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic aortic surgery: recent development in instrumentation. Alimi, YS., Mouret, F., Garitey, V., et al.[2006]

The microirrigator is a valuable tool for nerve and vessel repairs, effectively used in both experimental and clinical settings.

Its primary functions include hydrostatic dilatation of vessels and the removal of small blood clots, enhancing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microirrigator. Rigg, BM.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12488200/

Fetoscopic two‐layer closure for open neural tube defects This study confirms the feasibility, safety and effectiveness of the two‐layer fetoscopic repair technique with uterine exteriorization for ONTD ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05672849

Safety and Efficacy of Devices Used in Fetoscopic Neural ... The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair. Detailed ...

3. withpower.com withpower.com/trial/phase-neural-tube-defects-10-2022-76c74

Surgical Devices for Neural Tube Defects Trial Overview The study is testing the safety and effectiveness of modified surgical tools, including special sheaths and irrigators, used during fetoscopic ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06946563

NCT06946563 | Fetoscopic Neural Tube Defect Repair This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon ...

5. clinicaltrial.be clinicaltrial.be/en/details/177921?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Safety and Efficacy of Devices Used in Fetoscopic Neural... Modified Surgical Instruments/Devices (Sheaths and Irrigator). Device. Study arms: Modified Devices in fetoscopic NTD repair. Patients who ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05672849/safety-and-efficacy-of-devices-used-in-fetoscopic-neural-tube-defect-repair-cases

Safety and Efficacy of Devices Used in Fetoscopic Neural ... The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.