Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
ConditionNeural Tube Defects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMichael A Belfort
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who elect to undergo fetoscopic neural tube defect repair
Disqualifiers
Patients who do not elect to undergo fetoscopic neural tube defect repair
Trial design
Design model
Single group
Treatments tested in this trial
Modified Surgical Instruments/Devices (Sheaths and Irrigator)
DevicePatients who choose to undergo fetoscopic surgery will be offered participation in this study. All patients will undergo a fetoscopic repair of the fetal open neural tube defect with the use of the modified devices in this study.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Modified Devices in fetoscopic NTD repairExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of adverse events
Number of adverse events associated with the investigational device
Time frame
Immediate Post-Procedure period (until the leave the OR)2
Number of device defects, malfunctions, or failures
Number of device defects, malfunctions, or failures and whether the device performed as intended.
Time frame
Immediate Post-Procedure period (until the leave the OR)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael A Belfort
Lead sponsor
Baylor College of Medicine
Sponsor institution
Baylor College of Medicine
Collaborator
Source ClinicalTrials.gov