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

NCT06425471 | Recruiting FDA Device

• 1 other identifier: HSC-MS-22-1019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

In Utero Procedure Affecting Fetus or Newborn

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (11)

• 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

• Improved angle for laser visualization as assessed by the Likert scale

  within 24 hours of in utero surgery

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

  within 24 hours of in utero surgery

• Operative time in minutes

  end of surgery ( about 1 hour form start of surgery)

Study Arms (1)

KARL STORZ fetoscope arm

EXPERIMENTAL

Device: KARL STORZ fetoscope arm

Interventions

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)

KARL STORZ fetoscope arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Jimmy Espinoza, MD, MSc,FACOG

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmy Espinoza, MD, MSc,FACOG

CONTACT

(713) 500-5859; Jimmy.Espinoza@uth.tmc.edu

Elisa Garcia

CONTACT

713-500-6347; Elisa.I.Garcia@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)