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OpenTrials
Enrolling by Invitation

NCT Number: NCT06281730

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Karl Storz New Generation Fetoscope - curved 11508AAK

Device

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 11506AAK

Device

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.

Primary outcomes

  1. Adverse events

    Time frame: 12 months

    The count of subjects who experience adverse events

  2. Serious Adverse Events

    Time frame: 12 months

    The count of subjects who experience serious adverse events

  3. Device malfunctions

    Time frame: 12 months

    The number of device malfunction incidents

Secondary outcomes

  1. Mean gestational age at delivery

    Time frame: 12 months

    The mean gestational age at delivery. Measured in weeks.

  2. Successful Completion

    Time frame: 12 months

    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.

  3. Satisfaction scores

    Time frame: 12 months

    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.

  4. Live births

    Time frame: 12 months

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

  5. Neonatal deaths

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2024
Primary completion
2044
Study completion
2044
First posted
Feb 28, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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