What this study is
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
What's being tested
- KARL STORZ fetoscope arm
Intervention · 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)
Study details
- Official title
- A Prospective Study on the Efficacy of the Karl Storz Curved Fetoscope (11508aak) and Its Straight Version (11506akk) for In-utero Surgery
- Sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- In Utero Procedure Affecting Fetus or Newborn
- Enrolling
- 50 people
- Starts
- 2024-04-04
- Est. completion
- 2028-12-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex FEMALEHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas health Science Center at Houston
Houston, Texas, United States
- Jimmy Espinoza, MD, MSc,FACOG · Contact(713) 500-5859Jimmy.Espinoza@uth.tmc.edu
- Elisa Garcia · Contact713-500-6347Elisa.I.Garcia@uth.tmc.edu
Recruiting
Study team
Sponsor
The University of Texas Health Science Center, Houston
Study ID HSC-MS-22-1019
Principal investigator
Jimmy Espinoza, MD, MSc,FACOG
The University of Texas Health Science Center, Houston
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.