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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05672849
Recruitment Status : Recruiting
First Posted : January 5, 2023
Last Update Posted : January 5, 2023
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Michael A Belfort, Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Neural Tube Defects Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator) Not Applicable

Detailed Description:

All patients who choose to undergo fetoscopic neural tube defect repair at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent.

Fetoscopic Procedure: The fetoscopic open neural tube defect repair procedure will be performed with the same technique in this protocol as the investigators did in the previous protocols under this IDE (NCT02230072 and NCT03794011) in terms of exteriorization of the uterus, preparation for the fetoscopic repair and repair of the open neural tube defect. This involves release of the placode, dissection of the surrounding skin, development of myofascial flaps on either side of the defect, placement of a patch to be laid on top of the placode prior to closure of the myofascial flaps, suture of the flaps over the freed placode and patch and attempted primary closure of the defect using available skin. If necessary, the surgeons will use relaxing incisions or a skin patch to provide additional mobility to the skin to be closed over the defect. If the surgeons are unable to close the skin primarily despite best fetoscopic efforts, the option of performing/completing the repair as an open procedure exists and will be offered to the subject.

Follow-Up: The investigators will follow patients for the immediate post-procedure period (until they leave the OR).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Devices Used in Fetoscopic Neural Tube Defect Repair Cases
Actual Study Start Date : November 14, 2022
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Devices in fetoscopic NTD repair
Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices.
 Device: Modified Surgical Instruments/Devices (Sheaths and Irrigator)
Patients 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Immediate Post-Procedure period (until the leave the OR) ]
    Number of adverse events associated with the investigational device

  2. Number of device defects, malfunctions, or failures [ Time Frame: Immediate Post-Procedure period (until the leave the OR) ]
    Number of device defects, malfunctions, or failures and whether the device performed as intended.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who elect to undergo fetoscopic neural tube defect repair

Exclusion Criteria:

  • Patients who do not elect to undergo fetoscopic neural tube defect repair
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05672849


Contacts
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Contact: Michael A Belfort, MD 832-826-7375 belfort@bcm.edu
Contact: Becky Johnson 832-826-7451 rj2@bcm.edu

Locations
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United States, Texas
Texas Childrens Hospital - Pavilion for Women Recruiting
Houston, Texas, United States, 77030
Contact: Michael A Belfort, MD    832-826-7375    belfort@bcm.edu   
Contact: Becky Johnson    832-826-7451    rj2@bcm.edu   
Principal Investigator: Michael A Belfort, M.D.         
Sub-Investigator: Timothy Lee, M.D.         
Sub-Investigator: Magdalena Sanz Cortes, M.D., PhD         
Sub-Investigator: Ahmed Nassr, M.D.         
Sub-Investigator: Alice King, M.D.         
Sub-Investigator: Roopali Donepudi, MD         
Sub-Investigator: Sundeep Keswani, MD         
Sub-Investigator: William Whitehead, MD, MPH         
Sub-Investigator: Luc Joyeux, MD, PhD         
Sub-Investigator: Kwansoo Chun, PhD         
Sponsors and Collaborators
Michael A Belfort
Baylor College of Medicine
Investigators
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Principal Investigator: Michael A Belfort, MD Baylor College of Medicine and Texas Children's Hospital
More Information
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Responsible Party: Michael A Belfort, Chairman and Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05672849    
Other Study ID Numbers: H-51509
First Posted: January 5, 2023    Key Record Dates
Last Update Posted: January 5, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Michael A Belfort, Baylor College of Medicine:
myelomeningocele
MMC
NTD
neural tube defect
spina bifida
Additional relevant MeSH terms:
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Neural Tube Defects
Spinal Dysraphism
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities