Surgical Devices for Neural Tube Defects
Recruiting in Palo Alto (17 mi)
Overseen ByMichael A Belfort, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Michael A Belfort
Disqualifiers: Not electing for repair
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
12345How 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.
678910Eligibility Criteria
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.
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Modified Devices in fetoscopic NTD repairExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Texas Childrens Hospital - Pavilion for WomenHouston, TX
Loading ...
Who Is Running the Clinical Trial?
Michael A BelfortLead Sponsor
Baylor College of MedicineCollaborator
References
Manufacturer evaluations of endograft modifications. [2013]The motivation to modify the design of a vascular device can arise from a number of sources. Clinical experience with the unmodified device could suggest new design modifications to improve device performance or clinical outcomes. Similarly, clinical success with a device often suggests modifications that could broaden the applicability of the device to enable treatment of different or more advanced disease states. As a specific example, both of these scenarios have arisen during the last decade in the evolution of endovascular grafts for the treatment of abdominal aortic aneurysms, with modifications enabling the treatment of patients with shorter infrarenal necks, more angulated anatomy, and smaller access vessels. These modifications have been made by manufacturers and additionally by physicians who create branched and fenestrated devices. The experience to date with the use of fenestrated devices and the development of chimney, snorkel, and periscope techniques suggests that modifications to off-the-shelf devices may provide some clinical benefit. This experience provides additional motivation for manufacturers to develop devices to address the clinical needs not met with their current product lines. For manufacturers, the device development process includes an assessment of the new device design to determine the appropriate evaluation strategy to support the safety and effectiveness of the modified device. This report provides a high-level overview of the process generally followed by device manufacturers to evaluate a proposed device modification before market release, in accordance with local country regulations and recognized international standards such as the International Organization of Standardization (ISO) standards for endovascular grafts (ISO 25539 Part 1).
Laparoscopic aortic surgery: recent development in instrumentation. [2006]In addition to conventional and endovascular techniques, laparoscopic surgery is becoming a third way to treat patients with aortoiliac occlusive or aneurysmal diseases. Several different laparoscopic techniques are available, but most authors are stressing the need for development of specific laparoscopic aortic instruments, to decrease the operative and clamping times and reduce the learning curve. Our experience of more than 150 patients who underwent a laparoscopic abdominal or thoracic aortic reconstruction, has lead us to imagine the instruments that may facilitate these procedures, and then to create a society with Vascular Surgeons and Biomedical Engineers, called PROTOMED, which may conceive, develop, and test new medical instruments. This Chapter presents an overview of what is available currently, such as laparoscopic aortic clamps or laparoscopic intestinal retractors; others are in the experimental stage, such as laparoscopic aortic staplers, anastomotic devices, and robotic surgical systems. This important technologic challenge should lead to 2 major orientations: development of qualitative in vitro and in vivo experiments to test these new products, and training courses to teach their use. Minimally aggressive techniques are well adapted to a western population growing older and has access to constantly improving medical care; however, only specific and ergonomic instruments will allow these new techniques to be widely embraced by the vascular surgical community.
A novel arthroscopic pre-curved cannula with both flexibility and high stiffness. [2022]Curved surgical instruments are being developed to expand the workspace of straight surgical instruments. They are required to have a small diameter and high stiffness.
[Prospects of the use of new technology for producing precision instruments from glass]. [2011]The purpose of the work is the development and introduction into industry of the technology and equipment for manufacturing precision tubes from glass and other elements for medical instrumentation and equipment. The results of theoretical and experimental works are provided. Possible areas of the use of the technology and equipment are considered.
[New developements in endovascular infrarenal aortic aneurysm treatment]. [2022]New technical developments in endovascular aortic repair (EVAR) have broadened the range of patients eligible for minimally invasive aneurysm treatment. Optimization of delivery sheaths and catheters by considerable downsizing of diameters, increase of pushability and stability combined with flexibility are important parameters.
An inexpensive semiautomated irrigation/aspiration system. [2019]A new device for irrigating and aspirating the cortex is presented. The design features, including the module and disposable pack, and the method of use are described.
A microirrigator. [2019]The need for a microirrigator and the requirements for one are outlined. The method of construction is described. This instrument has been used in a variety of situations, both experimental and clinical, for nerve and vessel repairs. Probably its greatest value has been as an irrigating probe, both for hydrostatic dilatation of vessels and for floating away small clots of blood.
Design optimization of neuroendoscopic continuum instruments for third ventriculostomy and tumor biopsy. [2020]A simulation-based approach to the design of procedure-specific dexterous neuroendoscopic continuum instruments for endoscopic third ventriculostomy and tumor biopsy is proposed. Given pre-operative CT and MRI images, the algorithm returns instrument design specifications including lengths, curvatures and alternative positions for the surgical incision while respecting anatomical boundaries. This methodology proposes a novel clinically-guided geometric representation of surgical targets specific to this indication. The additional constraints imposed by the presence of surgical trocars and endoscopes are also considered. Finally, we conclude with a clinical example to demonstrate the proposed approach.
Irrigation device for neuroangiographic procedures. [2010]A simple irrigation device for use in diagnostic and interventional neuroangiographic procedures is described. The device is used to flush bubbles and blood clots from catheter hubs. The authors also describe a technique in which this device can be used to prevent filling a catheter with air when a guide wire is removed.
Endovascular tools available for the treatment of cerebrovascular disease. [2014]This article reviews essential neurointerventional tools approved in the United States, including catheters and wires, coils, flow diverters, balloons, stents, and devices for mechanical thrombectomy and thrombolysis. These devices are the result of decades of technical development; this article will also briefly trace the evolution of these devices, with an emphasis on the most influential developments.