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Surgical Device

Surgical Devices for Neural Tube Defects

N/A
Recruiting
Led By Michael A Belfort, MD
Research Sponsored by Michael A Belfort
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate post-procedure period (until the leave the or)
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety & effectiveness of tools used to fix birth defects in unborn babies.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on devices rather than drugs, side effects may include complications from surgery such as infection or damage to surrounding tissues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate post-procedure period (until the leave the or)
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate post-procedure period (until the leave the or) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of adverse events
Number of device defects, malfunctions, or failures

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Michael A BelfortLead Sponsor
4 Previous Clinical Trials
405 Total Patients Enrolled
Baylor College of MedicineOTHER
1,024 Previous Clinical Trials
6,029,410 Total Patients Enrolled
3 Trials studying Neural Tube Defects
99 Patients Enrolled for Neural Tube Defects
Michael A Belfort, MDPrincipal InvestigatorBaylor College of Medicine and Texas Children's Hospital
1 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Modified Surgical Instruments/Devices (Sheaths and Irrigator) (Surgical Device) Clinical Trial Eligibility Overview. Trial Name: NCT05672849 — N/A
Neural Tube Defects Research Study Groups: Modified Devices in fetoscopic NTD repair
Neural Tube Defects Clinical Trial 2023: Modified Surgical Instruments/Devices (Sheaths and Irrigator) Highlights & Side Effects. Trial Name: NCT05672849 — N/A
Modified Surgical Instruments/Devices (Sheaths and Irrigator) (Surgical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672849 — N/A
~60 spots leftby Dec 2027
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