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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Twin to Twin Transfusion Syndrome
• Intervention / Treatment: Device: Curved KARL STORZ fetoscope; Device: Conventional Scopes

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jimmy Espinoza, MD, MSc,FACOG; Phone Number: (713) 500-5859; Email: Jimmy.Espinoza@uth.tmc.edu
• Study Contact Backup: Name: Elisa Garcia; Phone Number: 713-500-6347; Email: Elisa.I.Garcia@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Elisa Garcia; Phone Number: 713-500-6347; Email: Elisa.I.Garcia@uth.tmc.edu
      • Contact: Jimmy Espinoza, MD,MSc,FACOG; Phone Number: 713-500-5859; Email: Jimmy.Espinoza@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KARL STORZ Curved Scope	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.
Active Comparator: Conventional scopes	Device: Conventional Scopes; The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time in minutes	Time from from operative cannula insertion until it is removed	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Total number of procedures with completion of the laser ablation		end of surgery (about 60 minutes after start of surgery)
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)
Total number of fetuses alive, after the laser photocoagulation procedure		at discharge from hospital (about 24 hours after surgery)
Total number of maternal patients that present with morbidity		at discharge from hospital (about 24 hours after surgery)
Total number of patients that have maternal and/or fetal perioperative complications		end of surgery (about 60 minutes after start of surgery)
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)		end of surgery (about 60 minutes after start of surgery)
Number of live births		at time of delivery (about 20 weeks from surgery)
Number of neonates with a short-term morbidity		from birth until hospital discharge
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
Number of Participants that have a gestational age of less than 37 weeks		at time of delivery (about 20 weeks from surgery)
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)

Collaborators and Investigators

• Sponsor: Jimmy Espinoza
• Investigators: Principal Investigator: Jimmy Espinoza, MD, MSc,FACOG, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Anemia, Neonatal; Fetofetal Transfusion
• Other Study ID Numbers: HSC-MS-23-0622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes