NCT06425471

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• In Utero Procedure Affecting Fetus or Newborn

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-04-04
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-05-22
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study