Recruiting

Karl Storz Fetoscopes

Sponsor:

Boston Children's Hospital

Code:

NCT06056635

Conditions

Fetal Conditions

Maternal; Procedure

Pregnancy Related

Twin to Twin Transfusion Syndrome

In Utero Procedure Affecting Fetus or Newborn

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Karl Storz Curved Scope

Karl Storz Straight Scope

Study Details

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

In Utero Procedure Affecting Fetus or Newborn

Study ID

NCT06056635

Start date

Aug 15, 2024

Status verified date

Sep, 2024

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Karl Storz Curved or Straight Scope

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.

Interventions

Karl Storz Curved Scope

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 Straight Scope

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.

Primary outcome measure

  • Rate of completed fetoscopic procedures [ Time Frame: 3 years from study start date ]
  • Fetal survival at birth [ Time Frame: When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date. ]

Central Contacts and Locations

Central contacts

Brittany Gudanowski

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

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Brittany Gudanowski

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

Fetal Care and Surgery Center

617-355-6512MFCCFetalResearchStudies-dl@childrens.harvard.edu

Principal Investigator:

Eyal Krispin, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Sep 25, 2024

Last verified

Sep, 2024

Keywords

  • Fetoscope
  • Fetoscopic Laser Ablation
  • Diagnostic Fetoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2024-09-25.