A PROSPECTIVE STUDY ON THE ROLE OF KARL STORZ CURVED AND STRAIGHT FETOSCOPES (11508AAK and 11506AAK) FOR FETOSCOPIC INTRAUTERINE PROCEDURES

Sponsor

Boston Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06056635

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this research study, we 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. We will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of these patients in order to evaluate the benefit of using these devices.

Condition or Disease	Intervention/Treatment	Phase
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	Device: Karl Storz Curved (11508AAK) and Straight (11506AAK) Fetoscopes	N/A

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. We will assess the surgical outcomes, short and long-term morbidity, complications, and gestational age of these patients. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A PROSPECTIVE STUDY ON THE ROLE OF KARL STORZ CURVED AND STRAIGHT FETOSCOPES (11508AAK and 11506AAK) FOR FETOSCOPIC INTRAUTERINE PROCEDURES

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

May 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Karl Storz Curved (11508AAK) and Straight (11506AAK) Fetoscopes These fetoscopes will be used to view target areas during in-utero procedures. 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.

Arm

Intervention/Treatment

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.

Device: Karl Storz Curved (11508AAK) and Straight (11506AAK) Fetoscopes

These fetoscopes will be used to view target areas during in-utero procedures. 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.

Outcome Measures

Primary Outcome Measures

Rate of completed fetoscopic procedures [3 years from study start date]
The rate of successfully completed intrauterine procedures (out of 50 total) using the Karl Storz Curved (11508AAK) or Straight (11506AAk) Fetoscope will be measured.
Fetal survival at birth [When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.]
The number of fetuses who undergo an intrauterine fetoscopic procedure using these devices and survive at birth will be analyzed.

Secondary Outcome Measures

Successful visualization of all targeted vessels [3 years from study start date]
The rate of procedures with these fetoscopes in which there is successful visualization of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.
Successful coagulation of all targeted vessels [3 years from study start date]
The rate of procedures with these fetoscopes in which there is successful coagulation of the targeted vessels will be studied. This measure will be at the discretion of the performing surgeon.
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 labor following a procedure using these fetoscopes will be analyzed.
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 PPROM following a procedure using these fetoscopes will be analyzed.
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.]
The rate of placental abruption following a procedure using these fetoscopes will be analyzed.
The rate of choriamniotic separation (CAS) [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 CAS following a procedure using these fetoscopes will be analyzed.
The rate of iatrogenic septostomy [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 iatrogenic septostomy following a procedure using these fetoscopes will be analyzed.
The rate of completed Solomonizations [3 years from study start date]
The rate of completed Solomonizations (if clinically elected to be performed) during a procedure using these fetoscopes will be analyzed.
The rate of any perioperative complications (within 24 hours post-procedure) [24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.]
The rate of any perioperative complications following a procedure using these fetoscopes will be analyzed.
Fetal survival 48 hours post-procedure [24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.]
The rate of fetal survival at 48 hours following a procedure using these fetoscopes will be analyzed.
Rate of TAPS [When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.]
In cases of twin-to-twin transfusion syndrome (TTTS) and selective fetal growth restriction (sFGR), the rate in which twin-anemia-polycythemia (TAPS) was observed following a procedure using these fetoscopes.
Recurrence of TTTS [When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.]
In cases of twin-to-twin transfusion syndrome (TTTS), the rate in which TTTS recurred following a procedure using these fetoscopes.
Neonatal survival 30 days after birth [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.]
The rate of neonatal survival at 30 days of life following a procedure using these fetoscopes will be analyzed.
Short term need for ECMO [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.]
The rate of ECMO initiation during the first 30 days of life following a procedure using these fetoscopes will be analyzed.
Short term morbidity [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.]
The rate of short term morbidity during the first 30 days of life following a procedure using these fetoscopes will be analyzed. Short-term morbidity includes neurological problems, gastrointestinal problems, respiratory problems, infections, and other problems associated with prematurity including but not limited to: necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, neonatal sepsis, and neonatal intensive care unit admission.
Gestational age at delivery [When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.]
Gestational age at delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.
Time from procedure to delivery [When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.]
Number of days from procedure to delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.
Length of procedure [3 years from study start date]
The length of time (in minutes) of the procedures using these fetoscopes will be analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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