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

NCT06084247 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HSC-MS-23-0622
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Twin to Twin Transfusion Syndrome

Outcome Measures

Primary Outcomes (1)

• Operative time in minutes

  Time from from operative cannula insertion until it is removed

  during surgery

Secondary Outcomes (12)

• Number of Participants that have a gestational age of less than 37 weeks

  at time of delivery (about 20 weeks from surgery)

• 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 visualization as assessed by the Likert scale

  end of surgery (about 60 minutes after start of surgery)

• Improved angle for laser visualization as assessed by the Likert scale

  end of surgery (about 60 minutes after start of surgery)

Study Arms (2)

KARL STORZ Curved Scope

EXPERIMENTAL

Device: Curved KARL STORZ fetoscope

Conventional scopes

ACTIVE COMPARATOR

Device: Conventional Scopes

Interventions

Curved KARL STORZ fetoscope DEVICE

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.

KARL STORZ Curved Scope

Conventional Scopes DEVICE

The conventional scopes are regularly used during laser photocoagulation of placental anastomoses.

Conventional scopes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jimmy Espinoza: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jimmy Espinoza, MD, MSc,FACOG

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jimmy Espinoza, MD, MSc,FACOG

CONTACT

(713) 500-5859; Jimmy.Espinoza@uth.tmc.edu

Elisa Garcia

CONTACT

713-500-6347; Elisa.I.Garcia@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)