A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery

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

Study Overview

• Status: Recruiting
• Conditions: In Utero Procedure Affecting Fetus or Newborn
• Intervention / Treatment: Device: KARL STORZ fetoscope arm

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jimmy Espinoza, MD, MSc,FACOG; Phone Number: (713) 500-5859; Email: Jimmy.Espinoza@uth.tmc.edu
• Study Contact Backup: Name: Elisa Garcia; Phone Number: 713-500-6347; Email: Elisa.I.Garcia@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Jimmy Espinoza, MD, MSc,FACOG; Phone Number: (713) 500-5859; Email: Jimmy.Espinoza@uth.tmc.edu
      • Contact: Elisa Garcia; Phone Number: 713-500-6347; Email: Elisa.I.Garcia@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KARL STORZ fetoscope arm	Device: KARL STORZ fetoscope arm; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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	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.	within 24 hours of in utero surgery
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	within 24 hours of in utero surgery
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	within 24 hours of in utero surgery
Operative time in minutes	Time from from operative cannula insertion until it is removed	end of surgery ( about 1 hour form start of surgery)
Number of fetuses alive prior to hospital discharge		time of discharge (about 48 hours after surgery)
Total number of maternal patients that present with short term morbidity	Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption	from end of surgery to within 10 weeks after surgery
Total number of patients that have maternal and/or fetal perioperative complications		from end of surgery to within 10 weeks 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)
Total number of short-term morbidities	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.	from time of in utero surgery till delivery (about 10 weeks after surgery)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Jimmy Espinoza, MD, MSc,FACOG, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-22-1019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes