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

Primary Purpose

Neural Tube Defects

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Modified Surgical Instruments/Devices (Sheaths and Irrigator)

About this trial

This is an interventional treatment trial for Neural Tube Defects focused on measuring myelomeningocele, MMC, NTD, neural tube defect, spina bifida

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Texas Childrens Hospital - Pavilion for WomenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified Devices in fetoscopic NTD repair

Arm Description

Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices.

Outcomes

Primary Outcome Measures

Number of adverse events

Number of adverse events associated with the investigational device

Number of device defects, malfunctions, or failures

Number of device defects, malfunctions, or failures and whether the device performed as intended.

Secondary Outcome Measures

Full Information

NCT ID

NCT05672849

First Posted

November 28, 2022

Last Updated

January 3, 2023

Sponsor

Michael A Belfort

Collaborators

Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05672849

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 14, 2022 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael A Belfort

Collaborators

Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neural Tube Defects

Keywords

myelomeningocele, MMC, NTD, neural tube defect, spina bifida

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Modified Devices in fetoscopic NTD repair

Arm Type

Experimental

Arm Description

Single arm study. All patients will undergo fetoscopic NTD repair with the use of the modified devices.

Intervention Type

Device

Intervention Name(s)

Modified Surgical Instruments/Devices (Sheaths and Irrigator)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of adverse events

Description

Number of adverse events associated with the investigational device

Time Frame

Immediate Post-Procedure period (until the leave the OR)

Title

Number of device defects, malfunctions, or failures

Description

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)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael A Belfort, MD

Phone

832-826-7375

belfort@bcm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Becky Johnson

Phone

832-826-7451

rj2@bcm.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael A Belfort, MD

Organizational Affiliation

Baylor College of Medicine and Texas Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Childrens Hospital - Pavilion for Women

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael A Belfort, MD

Phone

832-826-7375

belfort@bcm.edu

First Name & Middle Initial & Last Name & Degree

Becky Johnson

Phone

832-826-7451

rj2@bcm.edu

First Name & Middle Initial & Last Name & Degree

Michael A Belfort, M.D.

First Name & Middle Initial & Last Name & Degree

Timothy Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Magdalena Sanz Cortes, M.D., PhD

First Name & Middle Initial & Last Name & Degree

Ahmed Nassr, M.D.

First Name & Middle Initial & Last Name & Degree

Alice King, M.D.

First Name & Middle Initial & Last Name & Degree

Roopali Donepudi, MD

First Name & Middle Initial & Last Name & Degree

Sundeep Keswani, MD

First Name & Middle Initial & Last Name & Degree

William Whitehead, MD, MPH

First Name & Middle Initial & Last Name & Degree

Luc Joyeux, MD, PhD

First Name & Middle Initial & Last Name & Degree

Kwansoo Chun, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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