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The Use of Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

ConditionIn Utero Procedure Affecting Fetus or Newborn
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant woman

The patient fulfills the criteria for in-utero surgery based on the standard of care, which is specific for each condition

Patient of the baby provides signed informed consent that details the maternal and fetal risks involved with the procedure

Disqualifiers

Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia

Allergy or previous adverse reaction to a study medication specified in this protocol

Preterm labor, preeclampsia, or a uterine anomaly (e.g., large fibroid tumor) that is unavoidable during surgery in the index pregnancy

Fetal aneuploidy, genomic variants of known significance if an amniocentesis has been performed, other major fetal anomalies or disorders that may impact the fetal/neonatal survival, or a known syndromic mutation

Trial design

Design model

Single group

Treatments tested in this trial

  • KARL STORZ fetoscope arm

    Device

    The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: KARL STORZ fetoscope armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gestational age at delivery in patients requiring percutaneous in-utero surgery

Time frame
at time of delivery (about 10 weeks after in utero surgery)

Secondary outcomes

1

Number of successful procedures with completion of laser ablation of the abnormal vessels.

Time frame
within 24 hours of in utero surgery
2

Improved visualization as assessed by the Likert scale

This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes.

Time frame
within 24 hours of in utero surgery
3

Improved angle for laser visualization as assessed by the Likert scale

This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree

Time frame
within 24 hours of in utero surgery
4

Improved ease of use of the new fetoscope as assessed by a questionnaire

This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome

Time frame
within 24 hours of in utero surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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