Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy

N/AEnrolling By InvitationNCT06281730

Mayo Clinic100 enrolled

Overview

The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

100

Conditions

In Utero Procedure Affecting Fetus or Newborn

Interventions

Karl Storz New Generation Fetoscope - curved 11508AAKDEVICE

11508AAK Miniature straight forward telescope 0-degree set, curved, diameter 3.3 millimeter, length 30 centimeter, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 French., remote eyepiece, fiber optic light transmission incorporated.

Karl Storz New Generation Fetoscope - straight 11506AAKDEVICE

11506AAK Miniature straight forward telescope 0-degree, straight, diameter 3.3 millimeter, length 30 cm, 30,000 pixels, autoclavable, irrigation connector, central working channel 4 french, lateral working channel 3 french, remote eyepiece, fiber optic light transmission incorporated.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is a pregnant woman 18 and older * The mother must be healthy enough to have surgery * The mother must be scheduled for surgery * Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure Exclusion Criteria: * Age \<18 years * Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia * Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy. * Fetal aneuploidy, any significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray (if available, but not required), other major fetal anomalies that impacts significantly the fetal/neonatal survival.

Locations (1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Adverse events

The count of subjects who experience adverse events

Time frame: 12 months

Serious Adverse Events

The count of subjects who experience serious adverse events

Time frame: 12 months

Device malfunctions

The number of device malfunction incidents

Time frame: 12 months

Secondary Outcomes

Mean gestational age at delivery

The mean gestational age at delivery. Measured in weeks.

Time frame: 12 months

Successful Completion

The number of successful fetoscopic surgeries in twin twin transfusion syndrome. The measure of success is being able to ablate all anastomoses thought to be involved in causing the twin twin transfusion syndrome.

Time frame: 12 months

Satisfaction scores

Surgeon reported satisfaction of the use of the Karl Storz fetoscopes as measured by a 3 item Likert scale questionnaire. The 3 items are scored from 0 - 3, 0 being strongly disagree to 3 being strongly agree. Total scores range from 0 - 9, lower scores indicate less satisfaction, and higher scores indicate more satisfaction.

Time frame: 12 months

Live births

The number of subjects to have a live birth following in-utero surgery

Time frame: 12 months

Neonatal deaths

The number of subjects who experience a neonate death following in-utero surgery

Data from ClinicalTrials.gov

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