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?

The purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.

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.

How is the treatment using Modified Surgical Instruments/Devices for Neural Tube Defects different from other treatments?

This treatment is unique because it uses specially designed surgical tools, like sheaths and irrigators, to perform precise repairs on neural tube defects. These tools are adapted from devices used in other surgical procedures, allowing for more controlled and effective treatment compared to traditional methods. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Modified Surgical Instruments/Devices (Sheaths and Irrigator), Modified Surgical Instruments/Devices, Sheaths and Irrigator, Fetoscopic Repair Devices for Neural Tube Defects?

Research on endovascular grafts and laparoscopic aortic surgery suggests that modifying surgical devices can improve their performance and broaden their applicability to treat more complex conditions. This indicates that similar modifications in surgical instruments for neural tube defects could potentially enhance treatment outcomes. ^{6 7 8 9 10}

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

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]

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 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 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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Manufacturer evaluations of endograft modifications. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic aortic surgery: recent development in instrumentation. [2006]

3. England pubmed.ncbi.nlm.nih.gov

A novel arthroscopic pre-curved cannula with both flexibility and high stiffness. [2022]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Prospects of the use of new technology for producing precision instruments from glass]. [2011]

5. Germany pubmed.ncbi.nlm.nih.gov

[New developements in endovascular infrarenal aortic aneurysm treatment]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

An inexpensive semiautomated irrigation/aspiration system. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A microirrigator. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Design optimization of neuroendoscopic continuum instruments for third ventriculostomy and tumor biopsy. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Irrigation device for neuroangiographic procedures. [2010]

10. United States pubmed.ncbi.nlm.nih.gov

Endovascular tools available for the treatment of cerebrovascular disease. [2014]