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

Not Applicable

Recruiting

• Conditions: In Utero Procedure Affecting Fetus or Newborn
• Interventions: Device: KARL STORZ fetoscope arm

• Registration Number: NCT06425471
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Detailed Description

Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes

Study Timeline

• Study Start: 2024-04-04
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Suspicion of a major recognized syndrome by ultrasound or MRI
• Maternal BMI >40 kg/m2
• High risk for fetal hemophilia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KARL STORZ fetoscope arm	KARL STORZ fetoscope arm	-

Primary Outcome Measures

Name	Time	Method
Gestational age at delivery in patients requiring percutaneous in-utero surgery	at time of delivery (about 10 weeks after in utero surgery)

Secondary Outcome Measures

Name	Time	Method
Number of successful procedures with completion of laser ablation of the abnormal vessels.	within 24 hours of in utero surgery
Improved visualization as assessed by the Likert scale	within 24 hours of in utero surgery	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.
Improved ease of use of the new fetoscope as assessed by a questionnaire	within 24 hours of in utero surgery	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
Operative time in minutes	end of surgery ( about 1 hour form start of surgery)	Time from from operative cannula insertion until it is removed
Number of fetuses alive prior to hospital discharge	time of discharge (about 48 hours after surgery)
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)	from end of surgery to within 10 weeks after surgery
Total number of live births	from time of in utero surgery till delivery (about 10 weeks after surgery)
Improved angle for laser visualization as assessed by the Likert scale	within 24 hours of in utero surgery	This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree
Total number of patients that have maternal and/or fetal perioperative complications	from end of surgery to within 10 weeks after surgery
Total number of maternal patients that present with short term morbidity	from end of surgery to within 10 weeks after surgery	Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption
Total number of short-term morbidities	from time of in utero surgery till delivery (about 10 weeks after surgery)	Short-term morbidities include, but are not limited to, premature delivery (\<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis.

Trial Locations

Locations (1)

The University of Texas health Science Center at Houston; 🇺🇸 Houston, Texas, United States