Trial Outcomes & Findings for Fetoscopic NEOX Cord 1K® Spina Bifida Repair (NCT NCT04243889)

Results Overview

A digital image of the fetal repair site will be captured during and immediately after the repair. The images will be sent to three independent blinded neurosurgeons for review of successful closure of the defect. More than best of three votes will be considered as the result.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Immediately after repair procedure

Results posted on

2026-08-25

Participant Flow

50 Pregnant women were enrolled each with one fetus for a total of 100 participants enrolled.

Participant milestones

Participant milestones
Measure	NEOX Cord 1K Applied Fetoscopically - Pregnant Women Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled. NEOX Cord 1K: Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.	NEOX Cord 1K Applied Fetoscopically - Fetuses Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled. NEOX Cord 1K: Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
Overall Study STARTED	50	50
Overall Study Received Intervention	49	49
Overall Study COMPLETED	49	49
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fetoscopic NEOX Cord 1K® Spina Bifida Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NEOX Cord 1K Applied Fetoscopically n=50 Participants Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled. NEOX Cord 1K: Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
Age, Continuous	29 years n=31 Participants
Sex: Female, Male Female	50 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	3 Participants n=31 Participants
Race (NIH/OMB) White	35 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=31 Participants
Region of Enrollment United States	50 participants n=31 Participants

PRIMARY outcome

Timeframe: Immediately after repair procedure

A digital image of the fetal repair site will be captured during and immediately after the repair. The images will be sent to three independent blinded neurosurgeons for review of successful closure of the defect. More than best of three votes will be considered as the result.

Outcome measures

Outcome measures
Measure	NEOX Cord 1K Applied Fetoscopically n=49 Participants Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled. NEOX Cord 1K: Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
Number of Pregnant Women With Successful Fetoscopic Repair of the Defect Using NEOX Cord 1K®	49 Participants

SECONDARY outcome

Timeframe: Birth

Outcome measures

Outcome measures
Measure	NEOX Cord 1K Applied Fetoscopically n=49 Participants Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled. NEOX Cord 1K: Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
Number of Infants With Intact Repair of the Defect, Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site.	44 Participants

SECONDARY outcome

Timeframe: 12 months ± 2 months after birth

Population: Data include all infants who had data available at 12 months ± 2 months after birth.

Outcome measures

Outcome measures
Measure	NEOX Cord 1K Applied Fetoscopically n=49 Participants Patients intending to undergo open in-utero spina bifida repair, will be offered to be screened for an alternative minimally invasive approach. All eligible pregnant mothers' fetuses within the trial will receive NEOX Cord 1K® as a spinal cord cover to close the developmental defect. In some cases, at the discretion of the Neurosurgeon, NEOX Cord 1K® may be required to cover the skin. All eligible subjects meeting all inclusion criteria but none of the exclusion criteria may be enrolled. NEOX Cord 1K: Under general anesthesia and tocolysis, in-utero repair begins with a laparotomy that is followed by exteriorization of the uterus. The fetus is then positioned by external cephalic version. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Then, fetoscopically the placode will be examined and dissected. The lesion will be repaired using NEOX Cord 1K® (HUC) for closure of the first layer over the neural placode. Primary closure of the skin will then occur, or NEOX Cord 1K® (HUC) will be used for skin closure at the discretion of the neurosurgeon. Finally, the laparotomy site will be sutured in multiple layers.
Number of Infants With Intact Repair of the Defect as Defined as no Cerebrospinal Fluid Leakage and no Dehiscence at the Repair Site.	49 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: birth discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

Assessment of Arnold-Chiari malformation II as measured by MRI of head

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 ± 2 months, 30-36 months and 60-66 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 ± 2 months, 30-36 months and 60-66 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 ± 2 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: birth-discharge or 1 month + 30 days, 12 ± 2 months, and 60-66 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 ± 2 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30-36 months follow up post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 30-36 months and 60-66 months post delivery

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 60-66 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 ± 2 months; 30-36 months and 60-66 months post birth

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 ± 2 months, 30-36 months and 60-66 months post birth

Objective measures of the function of the lower urinary tract by evaluating post-void residual urine

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 ± 2 months, 30-36 months and 60-66 months post birth

Bowel function as assessed by observation of neurogenic bowel incontinence or constipation