Clinical trial NCT06056635: A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Official title: A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes (11508AAK and 11506AAK) for Fetoscopic Intrauterine Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Conditions
Maternal; Procedure
Pregnancy Related
Twin to Twin Transfusion Syndrome
In Utero Procedure Affecting Fetus or Newborn
Chorion; Abnormal
Twin Reversal Arterial Perfusion Syndrome
Twin Monochorionic Monoamniotic Placenta
Chorioangioma
Vasa Previa
Keywords: Fetoscope
Fetoscopic Laser Ablation
Diagnostic Fetoscopy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The objective of this study is to evaluate the benefit of Karl Storz curved (11508AAK) and straight (11506AAK) fetoscopes for in-utero surgery. The investigators will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of participants who undergo intrauterine procedures with these devices. The scopes will be used to assist in intrauterine procedures across a variety of fetal conditions, such as TTTS (twin-twin transfusion syndrome), TAPS (twin anemia polycythemia sequence), sFGR (selective fetal growth restriction) or TRAP sequence (twin reversed arterial perfusion). Fetoscopic laser photocoagulation (FLP) can also be used during in-utero surgery to correct abnormal vessels in cases like chorioangioma or vasa previa. Other complex congenital anomalies may require fetal intervention or diagnostic fetoscopy using Storz scopes.

Improvements in the technique, experience and equipment have been associated with better maternal, fetal, and neonatal outcomes in fetal surgery. Smaller fetoscopes are associated with lower rates of premature delivery following FLP. New fetoscopes (11508AAK and 11506AAK) have the potential to improve visualization and the photocoagulation angle. Compared to alternative scopes, these Storz scopes provide a wider angle of view and are longer, enabling better reach to distant areas at the edge of the placenta, especially in cases of higher BMI, higher gestational age, and significant polyhydramnios.

This study is an un-blinded, non-randomized, single arm, feasibility study on a convenience cohort to demonstrate the role of a curved fetoscope device (11508AAK) or straight fetoscope device (11506AAK) among in-utero surgeries. Patients will be enrolled in a consecutive manner and all qualifying, patients who agreed to the use of the curved or straight fetoscopes will be enrolled in the study. Outcome data will be reported as a descriptive statistical analysis. The curved fetoscope (11508AAK) device will be used in monochorionic pregnancies with an anterior placenta requiring in-utero surgery, while the straight fetoscope (11506AAK) will be used in monochorionic pregnancies with a posterior placenta. This device is classified as a significant risk device because it is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of completed fetoscopic procedures
timeFrame: 3 years from study start date
measure: Fetal survival at birth
timeFrame: When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.
Secondary outcomes:
measure: Successful visualization of all targeted vessels
timeFrame: 3 years from study start date
measure: Successful coagulation of all targeted vessels
timeFrame: 3 years from study start date
measure: The rate of preterm labor
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: The rate of preterm premature rupture of membranes (PPROM)
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: The rate of placental abruption
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: The rate of choriamniotic separation (CAS)
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: The rate of iatrogenic septostomy
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: The rate of completed Solomonizations
timeFrame: 3 years from study start date
measure: The rate of any perioperative complications (within 24 hours post-procedure)
timeFrame: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
measure: Fetal survival 48 hours post-procedure
timeFrame: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
measure: Rate of TAPS
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: Recurrence of TTTS
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: Neonatal survival 30 days after birth
timeFrame: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
measure: Short term need for ECMO
timeFrame: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
measure: Short term morbidity
timeFrame: When the last (50th) study participant reaches 30 days post-birth. This is likely to be a bit longer than 3 years from study start date.
measure: Gestational age at delivery
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: Time from procedure to delivery
timeFrame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
measure: Length of procedure
timeFrame: 3 years from study start date
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Fetal Surgeon
name: Eyal Krispin, MD
role: PRINCIPAL_INVESTIGATOR
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