The Efficacy of the KARL STORZ Curved Fetoscope and Straight Fetoscope for Laser Photocoagulation of Placental Anastomoses

Twin to Twin Transfusion Syndrome Clinical Trial

Official title:

An Open Label Randomized-control Study on the Efficacy of the KARL STORZ Curved Fetoscope (11508aak) and Its Straight Version (11506aak) for Laser Photocoagulation of Placental Anastomoses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06084247
• Other study ID #: HSC-MS-23-0622
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 1, 2027

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Jimmy Espinoza, MD, MSc,FACOG
• Phone: (713) 500-5859
• Email: Jimmy.Espinoza[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for laser photocoagulation of placental anastomoses in patients with an anterior placenta and Twin to Twin Transfusion Syndrome (TTTS).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnancy
• The patient fulfills the criteria for laser photocoagulation of placental anastomoses based on the standard of care
• fetal diagnosis of twin-to-twin transfusion syndrome
• Anterior placenta
• The patient 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
• The patient does not fulfill the conventional criteria to undergo in-utero surgery, which is specific for each surgery
• 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

Related Conditions & MeSH terms

• Fetofetal Transfusion
• Twin to Twin Transfusion Syndrome

Intervention

Device:
• Curved KARL STORZ fetoscope
The KARLZ STORZ curved scope is used to see the inside of a pregnant person's uterus during minimally invasive surgery, similar to conventional scopes. The curved scope is rounded and thought to help visualize the anterior placenta because of its position on the uterus.
• Conventional Scopes
The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Jimmy Espinoza

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time in minutes	Time from from operative cannula insertion until it is removed	during surgery
Secondary	Number of Participants that have a gestational age of less than 37 weeks		at time of delivery (about 20 weeks from surgery)
Secondary	Number of times additional fetoscopes are entered into the amniotic cavity to confirm completion of the in-utero intervention		end of surgery (about 60 minutes after start of surgery)
Secondary	Total number of procedures with completion of the laser ablation		end of surgery (about 60 minutes after start of surgery)
Secondary	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.	end of surgery (about 60 minutes after start of surgery)
Secondary	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	end of surgery (about 60 minutes after start of surgery)
Secondary	Total number of fetuses alive, after the laser photocoagulation procedure		at discharge from hospital (about 24 hours after surgery)
Secondary	Total number of maternal patients that present with morbidity		at discharge from hospital (about 24 hours after surgery)
Secondary	Total number of patients that have maternal and/or fetal perioperative complications		end of surgery (about 60 minutes after start of surgery)
Secondary	The number of participants that develop twin-anemia-polycythemia sequence (TAPS)		end of surgery (about 60 minutes after start of surgery)
Secondary	Number of live births		at time of delivery (about 20 weeks from surgery)
Secondary	Number of neonates with a short-term morbidity		from birth until hospital discharge
Secondary	Infant development score using the Ages & Stages Questionnaires, Third Edition (ASQ-3)	Scored items on ASQ-3 address 5 areas of child development: communication, gross motor, Fine motor, problem solving, and personal-social and each of these have 6 questions each and is scored as yes( 10 points), sometimes (5 points) and not yet (0 points)-the total score is calculated for each area and scores should fall between 0-60, and a higher score indicates more development.; There is a 9 item overall developmental section that is answered categorically as yes or no answer	24 months of age