Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056635
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-09-21
Brief Title:
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes 11508AAK and 11506AAK for Fetoscopic Intrauterine Procedures
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
A Prospective Study on the Role of Karl Storz Curved and Straight Fetoscopes 11508AAK and 11506AAK for Fetoscopic Intrauterine Procedures
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None