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

NCT ID: NCT06084247

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-01

Brief Summary

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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).

Detailed Description

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Conditions

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Twin to Twin Transfusion Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KARL STORZ Curved Scope

Group Type EXPERIMENTAL

Curved KARL STORZ fetoscope

Intervention Type 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.

Conventional scopes

Group Type ACTIVE_COMPARATOR

Conventional Scopes

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Conventional Scopes

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jimmy Espinoza

OTHER

Sponsor Role lead

Responsible Party

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Jimmy Espinoza

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jimmy Espinoza, MD, MSc,FACOG

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Jimmy Espinoza, MD, MSc,FACOG

Role: CONTACT

(713) 500-5859

Elisa Garcia

Role: CONTACT

713-500-6347

Facility Contacts

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Jimmy Espinoza, MD,MSc,FACOG

Role: primary

(713) 500-5859

Elisa Garcia

Role: backup

713-500-6347

Other Identifiers

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HSC-MS-23-0622

Identifier Type: -

Identifier Source: org_study_id

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