A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures

NCT06056635 | Recruiting DMC FDA Device

• 1 other identifier: IRB-P00044063
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study, the investigators want to learn more about the role of new innovative surgical devices, the Karl Storz Curved and Straight Fetoscopes for in-utero surgery. A fetoscope is like a small telescope that can see inside of the uterus (womb) during minimally invasive surgery. The curved scope is used for patients with an anterior placenta (front of uterus), while the straight scope is used for patients with a posterior placenta (back of uterus). The scopes will be used to assist in procedures involving fetoscopic laser photocoagulation (FLP), which is a minimally invasive surgery that uses a small camera (fetoscope) to locate abnormal blood vessel connections in the placenta and seal them off using laser energy. These fetoscopes will be utilized in the diagnosis and management of various fetal conditions that can arise during pregnancy. Outcome data will be reported in a descriptive statistical analysis. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants in order to evaluate the benefit of using these devices.

Conditions

Fetal Conditions; Maternal; Procedure; Pregnancy Related; Twin to Twin Transfusion Syndrome; Chorion; Abnormal; Twin Reversal Arterial Perfusion Syndrome; Twin Monochorionic Monoamniotic Placenta; Chorioangioma; Vasa Previa; In Utero Procedure Affecting Fetus or Newborn

Keywords

Fetoscope; Fetoscopic Laser Ablation; Diagnostic Fetoscopy

Outcome Measures

Primary Outcomes (2)

• Rate of completed fetoscopic procedures

  The rate of successfully completed intrauterine procedures (out of 50 total) using the Karl Storz Curved (11508AAK) or Straight (11506AAk) Fetoscope will be measured.

  3 years from study start date

• Fetal survival at birth

  The number of fetuses who undergo an intrauterine fetoscopic procedure using these devices and survive at birth will be analyzed.

  When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.

Secondary Outcomes (18)

• Successful visualization of all targeted vessels

  3 years from study start date

• Successful coagulation of all targeted vessels

  3 years from study start date

• The rate of preterm labor

  When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.

• The rate of preterm premature rupture of membranes (PPROM)

  When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.

• The rate of placental abruption

  When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.

Study Arms (1)

Karl Storz Curved or Straight Scope

EXPERIMENTAL

A Karl Storz Curved (11508AAK) or Straight (11506AAK) Fetoscope will be used to provide visualization during in-utero (in the womb) diagnostic and interventional procedures. The curved scope will be used in patients with a placenta that sits at the front of their uterus. The straight scope will be used in patients with a placenta that sits at the back of their uterus.

Device: Karl Storz Curved Scope; Device: Karl Storz Straight Scope

Interventions

Karl Storz Curved Scope DEVICE

The curved fetoscope (11508AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the front of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.

Karl Storz Curved or Straight Scope

Karl Storz Straight Scope DEVICE

The straight fetoscope (11506AAK) will be used to view target areas during in-utero procedures for patients with a placenta that sits at the back of the uterus. There are various fetal conditions that may require use of a fetoscope during minimally invasive surgery. These include the need to seal vessels in order to stop blood flow going in a specific direction during pregnancy, abnormal vessels that may need to be sealed, or to break down scar tissue, extra tissue attachments, or blockages.

Karl Storz Curved or Straight Scope

Eligibility Criteria

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

You may qualify if:

• Pregnant patient with a condition requiring in-utero surgery
• Patient must be eligible for anesthesia
• Patient and father of the fetus (if available) are able to provide signed informed consent

You may not qualify if:

• Allergy or previous adverse reaction to any ancillary medication specified in this protocol that has no alternative
• Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy
• Suspicion of major recognized congenital syndrome on ultrasound or MRI that is not compatible with postnatal life
• Pre-pregnancy maternal BMI greater than 40
• High risk for fetal hemophilia
• Fetal aneuploidy or variants of known significance if an amniocentesis was performed
• Contraindication to abdominal surgery or fetoscopic surgery

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Fetofetal Transfusion; Antisocial Personality Disorder; Hemangioma; Vasa Previa

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Personality Disorders; Mental Disorders; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Eyal Krispin, MD

  Fetal Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Gudanowski

CONTACT

617-919-6658; Brittany.Gudanowski@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Maternal Fetal Care Center

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: August 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)