A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
The University of Texas health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Jimmy Espinoza, MD, MSc,FACOG
Jimmy.Espinoza@uth.tmc.edu
(713) 500-5859
Backup
Elisa Garcia
Elisa.I.Garcia@uth.tmc.edu
713-500-6347
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 50
Treatments
Experimental: KARL STORZ fetoscope arm
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston