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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate post-procedure period (until the leave the or)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of adverse events

Number of device defects, malfunctions, or failures

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.

Do I qualify?Apply below to find out

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

1,002 Previous Clinical Trials

6,002,704 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up for this clinical research initiative?

"Affirmative. Information hosted on clinicaltrials.gov demonstrates that this research endeavour, which was first advertised on November 14th 2022, is actively seeking participants. 100 people need to be enrolled from 1 various medical facilities."

Answered by AI

Are there any open slots available in this clinical research project?

"This clinical trial is currently in the process of enrolling participants. According to the information posted on clincialtrials.gov, it was first made available on November 14th 2022 and has been recently modified on January 3rd 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases

Michael A Belfort 2022. "Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05672849.

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