An interventional study of Karl Storz Curved Scope and Karl Storz Straight Scope in Fetal Conditions, Maternal; Procedure and Pregnancy Related, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
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.
47 studies on the registry are indexed under Fetofetal Transfusion; 10 are open to participants now.
This study's planned enrollment of 50 is below the median of 128 across 32 interventional studies indexed under Fetofetal Transfusion.
Browse Fetofetal Transfusion studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 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.
Time frame: When the last (50th) study participant reaches birth. Likely to be a bit more than 3 years from study start date.
Successful visualization of all targeted vessels
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.
Time frame: 3 years from study start date
Successful coagulation of all targeted vessels
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.
Time frame: 3 years from study start date
The rate of preterm labor
The rate of preterm labor following a procedure using these fetoscopes will be analyzed.
Time frame: 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)
The rate of PPROM following a procedure using these fetoscopes will be analyzed.
Time frame: 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
The rate of placental abruption following a procedure using these fetoscopes will be analyzed.
Time frame: 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 choriamniotic separation (CAS)
The rate of CAS following a procedure using these fetoscopes will be analyzed.
Time frame: 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
The rate of iatrogenic septostomy following a procedure using these fetoscopes will be analyzed.
Time frame: 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 completed Solomonizations
The rate of completed Solomonizations (if clinically elected to be performed) during a procedure using these fetoscopes will be analyzed.
Time frame: 3 years from study start date
The rate of any perioperative complications (within 24 hours post-procedure)
The rate of any perioperative complications following a procedure using these fetoscopes will be analyzed.
Time frame: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Fetal survival 48 hours post-procedure
The rate of fetal survival at 48 hours following a procedure using these fetoscopes will be analyzed.
Time frame: 24 hours after the last (50th) procedure using these fetoscopes. This will be a bit more than 3 years from study start date.
Rate of TAPS
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.
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Recurrence of TTTS
In cases of twin-to-twin transfusion syndrome (TTTS), the rate in which TTTS recurred following a procedure using these fetoscopes.
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Neonatal survival 30 days after birth
The rate of neonatal survival at 30 days of life following a procedure using these fetoscopes will be analyzed.
Time frame: 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.
Short term need for ECMO
The rate of ECMO initiation during the first 30 days of life following a procedure using these fetoscopes will be analyzed.
Time frame: 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.
Short term morbidity
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.
Time frame: 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.
Gestational age at delivery
Gestational age at delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Time from procedure to delivery
Number of days from procedure to delivery will be analyzed for study participants who undergo a procedure using these fetoscopes.
Time frame: When the last (50th) study participant reaches birth. This is likely to be a bit longer than 3 years from study start date.
Length of procedure
The length of time (in minutes) of the procedures using these fetoscopes will be analyzed.
Time frame: 3 years from study start date
Plan to share: No
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